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Clohesy, Natalie C., Anthony G. Schneiders, and Sharyn Eaton. "Utilization of Low Back Pain Patient Reported Outcome Measures Within Chiropractic Literature: A Descriptive Review." Journal of Manipulative and Physiological Therapeutics 41, no. 7 (September 2018): 628–39. http://dx.doi.org/10.1016/j.jmpt.2017.11.007.
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Hays, Ron D., Karen L. Spritzer, and Steven P. Reise. "Using Item Response Theory to Identify Responders to Treatment: Examples with the Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function Scale and Emotional Distress Composite." Psychometrika 86, no. 3 (June 12, 2021): 781–92. http://dx.doi.org/10.1007/s11336-021-09774-1.
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AbstractThe reliable change index has been used to evaluate the significance of individual change in health-related quality of life. We estimate reliable change for two measures (physical function and emotional distress) in the Patient-Reported Outcomes Measurement Information System (PROMIS®) 29-item health-related quality of life measure (PROMIS-29 v2.1). Using two waves of data collected 3 months apart in a longitudinal observational study of chronic low back pain and chronic neck pain patients receiving chiropractic care, and simulations, we compare estimates of reliable change from classical test theory fixed standard errors with item response theory standard errors from the graded response model. We find that unless true change in the PROMIS physical function and emotional distress scales is substantial, classical test theory estimates of significant individual change are much more optimistic than estimates of change based on item response theory.
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Thoomes, Erik, Gus Tilborghs, Nicola R. Heneghan, Deborah Falla, and Marloes de Graaf. "Effectiveness of thoracic spine manipulation for upper quadrant musculoskeletal disorders: protocol for a systematic review." BMJ Open 13, no. 9 (September 2023): e076143. http://dx.doi.org/10.1136/bmjopen-2023-076143.
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IntroductionUpper quadrant musculoskeletal disorders (UQMD), comprising of cranial, cervical, shoulder and upper extremity disorders, are among the most frequently reported disorders in clinical practice. Thoracic high velocity low amplitude thrust (Tx-HVLAT) manipulation is a form of conservative management recommended in systematic reviews as an effective treatment option for aspects of UQMD disorders such headache, shoulder pain and lateral elbow pain. However, no recent systematic reviews have assessed the effectiveness across UQMD. Therefore, this systematic review aims to update the current evidence on the effectiveness of Tx-HVLAT for patients with UQMD on (1) patient-reported outcomes, (2) performance measures or (3) psychosocial outcomes.Methods and analysisThe Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, PEDro and Index to Chiropractic Literature will be searched from inception using Medical Subject Headings (MeSH), Thesaurus and/or free-text words. Combinations will be made based on localisation, disorder, intervention and design. Following guidelines as advised by the Cochrane Back Review Group, published randomised controlled trials will be included. Two review authors will independently assess the risk of bias (ROB) using the Cochrane Back Review Group’s recommended ROB2 tool and will independently extract the data using a standardised data extraction form. Overall quality of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. For continuous data, we will calculate standardised mean differences with 95% CIs. For dichotomous outcomes, relative risks and 95% CIs will be calculated. Where possible we will present a subgroup analysis by disorder. For pooling, a random-effects model will be used.Ethics and disseminationEthics approval is not required for this systematic review. The study findings will be submitted to a relevant peer-reviewed journal for dissemination and presented at relevant conferences.PROSPERO registration numberCRD42023429996.
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Rogers, Casey, Madeleine Hackney, Lisa Zubkoff, and Katharina Echt. "ACTIVITY GOAL SETTING ON CHRONIC LOWER BACK PAIN FOR OLDER VETERANS RECEIVING CHIROPRACTIC CARE." Innovation in Aging 6, Supplement_1 (November 1, 2022): 797–98. http://dx.doi.org/10.1093/geroni/igac059.2878.
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Abstract There is currently no literature addressing the impact that chiropractic services have on older adults achieving individualized specific goals throughout a course of care for chronic low back pain. This study aims to explore the impact of setting a self-determined, “what matters most” activity/goal of rehabilitation care with relevant activities as part of standard chiropractic care on the self-rated pain and disability of older Veterans. Participants were randomized into two groups. The first, an experimental group where participants identified a goal and received standard chiropractic care. The second, a control group that received standard chiropractic care only. Participants underwent six sessions of care. Outcome assessment tools were utilized at pre- and post-treatment for both groups as primary measures and an individualized goal setting measurement tool was utilized for those randomized to the experimental group. After treatment, all participants had self-reported improvement in their condition and all participants assigned to a “goal setting group” achieved their desired goal. Despite some outcome measures remaining unchanged, this self-reported improvement may be important in the future of chiropractic services for the older Veteran population suffering with chronic low back pain in achieving self-determined goals of importance.
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Alhowimel, Ahmed, Faris Alodaibi, Mazyad Alotaibi, Dalyah Alamam, and Julie Fritz. "The Patient-Reported Outcome Measures Used with Low Back Pain and the Attitude of Primary Healthcare Practitioners in Saudi Arabia toward Them." Medicina 57, no. 8 (August 8, 2021): 812. http://dx.doi.org/10.3390/medicina57080812.
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Background and objectives: The use of appropriate outcome measures can help guide multidimensional low back pain (LBP) management, elucidate the efficacy/effectiveness of interventions, and inform clinicians when selected targets have been achieved and this can be used for educational or research purposes. Aim: This study aimed to explore and describe the use, attitudes, knowledge, and beliefs regarding patient-reported outcome measures used by healthcare practitioners practising in Saudi Arabia who are frequently involved in the healthcare of individuals with LBP. Materials and Methods: A cross-sectional design was undertaken using a web-based survey. An electronic invitation to participate was sent to primary care physicians and physical therapists practising in Saudi Arabia. The survey included three sections: demographic data, a list of the most commonly used patient-reported outcome measures with LBP patients, and statements regarding attitudes, knowledge, and beliefs about outcome measures. Results: A total of 156 practitioners participated: 45 primary care physicians and 111 physical therapists. The numeric pain rating and visual analogue scales were the outcome measures most frequently reported as being often used by both primary care physicians and physical therapists. The majority of participants reported often using 1–2 patient reported outcome measures (PROMs). While most participants indicated that they were confident at selecting the most appropriate PROM, fewer were familiar with the concept of the minimally important clinical difference. A lack of Arabic versions of PROMs was reported as a barrier to using them to assess pain. Conclusions: This study shows that, although primary care physicians and physical therapists in Saudi Arabia frequently use patient-reported outcome measures in their clinical management of patients with LBP, there is a noticeable gap in the knowledge and use of the multidimensional outcome measures for LBP management among the participants. This highlights a need for professional training on the use of standardised outcome measures related to LBP.
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Sigmundsson, Freyr Gauti, Anders Joelson, and Fredrik Strömqvist. "Patients with no preoperative back pain have the best outcome after lumbar disc herniation surgery." European Spine Journal 31, no. 2 (October 27, 2021): 408–13. http://dx.doi.org/10.1007/s00586-021-07033-6.
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Abstract Purpose Most patients with lumbar disc herniations requiring surgery have concomitant back pain. The purpose of the current study was to evaluate the outcome of surgery for lumbar disc herniations in patients with no preoperative back pain (NBP) compared to those reporting low back pain (LBP). Methods 15,418 patients surgically treated due to LDH with primary discectomy from 1998 until 2020 were included in the study. Self-reported low back pain assessed with a numerical rating scale (NRS) was used to dichotomize the patients in two groups, patients without preoperative back pain (NBP, NRS = 0, n = 1333, 9%) and patients with preoperative low back pain (LBP, NRS > 0, n = 14,085, 91%). Patient reported outcome measures (PROMs) collected preoperatively and one-year postoperatively were used to evaluate differences in outcomes between the groups. Results At the one-year follow-up, 89% of the patients in the NBP group were completely pain free or much better compared with 76% in the LBP group. Significant improvement regarding leg pain was seen in all measured PROMs in both groups oneyear after surgery. In the NBP group, 13% reported clinically significant back pain (NRS difference greater than Minimally Clinical Important Difference (MICD)) at the one-year follow-up. Conclusions Patients without preoperative back pain are good candidates for LDH surgery. 13% of patients without preoperative back pain develop clinically significant back pain one-year after surgery.
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Miki, Takahiro, Yu Kondo, Tsuneo Takebayashi, and Hiroshi Takasaki. "Difference between physical therapist estimation and psychological patient-reported outcome measures in patients with low back pain." PLOS ONE 15, no. 1 (January 21, 2020): e0227999. http://dx.doi.org/10.1371/journal.pone.0227999.
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Gold, Laura S., Matthew Bryan, Bryan A. Comstock, Brian W. Bresnahan, Richard A. Deyo, Srdjan S. Nedeljkovic, David R. Nerenz, Patrick Heagerty, and Jeffrey G. Jarvik. "Associations Between Relative Value Units and Patient-Reported Back Pain and Disability." Gerontology and Geriatric Medicine 3 (January 1, 2017): 233372141668601. http://dx.doi.org/10.1177/2333721416686019.
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Objective: To describe associations between health care utilization measures and patient-reported outcomes (PROs). Method: Primary data were collected from patients ≥65 years with low back pain visits from 2011 to 2013. Six PROs of pain and functionality were collected 12 and 24 months after the index visits and total and spine-specific relative value units (RVUs) from electronic health records were tabulated over 1 year. We calculated correlation coefficients between RVUs and 12- and 24-month PROs and conducted linear regressions with each 12- and 24-month PRO as the outcome variables and RVUs as predictors of interest. Results: We observed very weak correlations between worse PROs at 12 and 24 months and greater 12-month utilization. In regression analyses, we observed slight associations between greater utilization and worse 12- and 24-month PROs. Discussion: We found that 12-month health care utilization is not strongly associated with PROs at 12 or 24 months.
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Hanney, William J., Fahim Dhalla, Chase Kelly, Alicia Tomberlin, Morey J. Kolber, Abigail T. Wilson, and Paul A. Salamh. "The Influence of Personality Type on Patient Outcome Measures and Therapeutic Alliance in Patients with Low Back Pain." NeuroSci 4, no. 3 (August 7, 2023): 186–94. http://dx.doi.org/10.3390/neurosci4030017.
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Background: Low back pain (LBP) has been shown to have various biological, psychological, and social factors that affect prognosis. However, it is unclear how personality may influence self-reported outcome measures and therapeutic alliance (TA). Methods: Eysenck’s personality inventory was used to assess personality, while the numeric pain rating scale (NPRS), Oswestry Disability Index (ODI), Tampa Scale of Kinesiophobia (TSK), Global Rating of Change (GROC), and the Working Alliance Inventory (WAI) measured patient progress and relationship strength. All outcome measures were formulated in a single survey that both the therapist and patient completed electronically. Results: Sixty-seven patients with LBP and twenty-two licensed physical therapists participated. For personality measures, there was a significant positive correlation between neuroticism and GROC (rho = 0.295, p = 0.015) and a significant negative correlation between extraversion and WAI (rho = −0.243, p = 0.048). Significant correlations were found between ODI and TSK (rho = 0.462, p ≤ 0.001) and between ODI and GROC (rho = −0.416, p ≤ 0.001). A significant negative correlation was found between TSK and GROC (rho = −0.301, p = 0.013). Conclusions: Patients with higher levels of disability seemed to report higher levels of kinesiophobia and less overall improvement in physical therapy. Patients classified as neurotic reported higher levels of improvement while extraverted patients demonstrated a weaker therapeutic alliance with their therapist.
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Östhols, Sara, Carina Boström, and Eva Rasmussen-Barr. "Clinical assessment and patient-reported outcome measures in low-back pain – a survey among primary health care physiotherapists." Disability and Rehabilitation 41, no. 20 (May 9, 2018): 2459–67. http://dx.doi.org/10.1080/09638288.2018.1467503.
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Pires, Diogo, Eduardo Brazete Cruz, Luís A. Gomes, and Carla Nunes. "How Do Physical Therapists Measure Treatment Outcomes in Adults With Chronic Low Back Pain? A Systematic Review." Physical Therapy 100, no. 6 (March 2, 2020): 1020–34. http://dx.doi.org/10.1093/ptj/pzaa030.
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Abstract Background There is an increasing recognition of the importance of using a conceptual framework covering the full range of relevant health domains and outcome measures addressed by physical therapy modalities in patients with chronic low back pain (CLBP). However, little is known about what outcome domains have been measured and through what measures in physical therapy research. Objective The purpose of this review was to synthesize outcome domains, instruments, and cutoff values reported in published randomized controlled trials and their compliance with the original Patient-Reported Outcomes Measurement Information System (PROMIS) framework. Data sources Embase, MEDLINE, Cochrane Library, and Physiotherapy Evidence Database electronic databases were systematically searched from January 2008 to April 2019. Study selection Randomized controlled trials that compared physical therapy with any other intervention for adults with CLBP were included. Data extraction Study characteristics, outcome domains, instruments, and cutoff values were extracted by 2 reviewers. The PROMIS framework was used for domain categorization. Data synthesis One hundred ninety-five studies were included, with 52 outcome domains and 45 cutoff values identified from 182 instruments reported. Only 14 of 195 studies assessed all PROMIS health core areas, whereas the PROMIS physical health core area was assessed in all included studies. Pain intensity and disability were the most frequently used domains. Limitations Only studies for which full texts were available in English were included. Conclusions This review identified a poor overlap between the PROMIS framework and outcome domains used to define the effectiveness of physical therapy in adults with CLBP. This finding suggests that other potential benefits resulting from physical therapy modalities are not being measured. Furthermore, a large diversity in the outcome domains and instruments was found.
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Strömqvist, Fredrik, Björn Strömqvist, Bo Jönsson, Paul Gerdhem, and Magnus K. Karlsson. "Predictive outcome factors in the young patient treated with lumbar disc herniation surgery." Journal of Neurosurgery: Spine 25, no. 4 (October 2016): 448–55. http://dx.doi.org/10.3171/2016.2.spine16136.
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OBJECTIVE The aim of this study was to evaluate predictive factors for outcome after lumbar disc herniation surgery in young patients. METHODS In the national Swedish spine register, the authors identified 180 patients age 20 years or younger, in whom preoperative and 1-year postoperative data were available. The cohort was treated with primary open surgery due to lumbar disc herniation between 2000 and 2010. Before and 1 year after surgery, the patients graded their back and leg pain on a visual analog scale, quality of life by the 36-Item Short-Form Health Survey and EuroQol–5 Dimensions, and disability by the Oswestry Disability Index. Subjective satisfaction rate was registered on a Likert scale (satisfied, undecided, or dissatisfied). The authors evaluated if age, sex, preoperative level of leg and back pain, duration of leg pain, pain distribution, quality of life, mental status, and/or disability were associated with the outcome. The primary end point variable was the grade of patient satisfaction. RESULTS Lumbar disc herniation surgery in young patients normalizes quality of life according to the 36-Item Short-Form Health Survey, and only 4.5% of the patients were unsatisfied with the surgical outcome. Predictive factors for inferior postoperative patient-reported outcome measures (PROM) scores were severe preoperative leg or back pain, low preoperative mental health, and pronounced preoperative disability, but only low preoperative mental health was associated with inferiority in the subjective grade of satisfaction. No associations were found between preoperative duration of leg pain, distribution of pain, or health-related quality of life and the postoperative PROM scores or the subjective grade of satisfaction. CONCLUSIONS Lumbar disc herniation surgery in young patients generally yields a satisfactory outcome. Severe preoperative pain, low mental health, and severe disability increase the risk of reaching low postoperative PROM scores, but are only of relevance clinically (low subjective satisfaction) for patients with low preoperative mental health.
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Dorfman, David, Mary Catherine George, Jessica Robinson-Papp, Tanni Rahman, Ronald Tamler, and David M. Simpson. "Patient reported outcome measures of pain intensity: Do they tell us what we need to know?" Scandinavian Journal of Pain 11, no. 1 (April 1, 2016): 73–76. http://dx.doi.org/10.1016/j.sjpain.2015.12.004.
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AbstractObjectiveTo determine the relationship between chronic pain patients’ responses to self-report measures of pain intensity, and self-reported strategies when completing such measures.ParticipantsAmbulatory outpatients suffering from one of the following chronic pain conditions: painful HIV neuropathy, painful diabetic neuropathy, chronic Low-Back Pain.MethodAs part of a previously reported study using qualitative methods, participants completed standard pain intensity questionnaires as well as a measure of pain related disturbances in activities of daily living. In the previous study, participants’ responses during a focus group were then used to identify their strategies and beliefs about their approach to completing the questionnaires. Among the beliefs were: (1) difficulties averaging pain over different time periods (i.e., “what was your average pain during the last 24h” versus “what was your average pain during the last 2 weeks”); (2) difficulty in comparing pain from different etiologies; (3) difficulties in reporting sensations of pain in a manner unaffected by issues and situations secondary to the pain experience, such as difficulties in activities of daily living. In the present paper we use ANOVA (analysis of variance) and partial correlation to determine whether the qualitatively derived perceptions are reflected in the quantitative pain intensity scores.ResultsParticipants’ belief that it was difficult to “average” pain intensity over different time periods was supported. The data do not support their belief that pain intensity scores are affected by other factors: their specific pain diagnosis, and the extent to which pain interfered with their activities of daily living.Conclusions(1) Patients tend to report different levels of pain intensity when asked to report their pain over different periods; (2) insofar as it can be said to exist, the relationship between measures of intensity and interference with activities of daily living is minimal; (3) participants tend to report similar levels of pain intensity, irrespective of etiology.Implications(1) Chronic pain patients’ elicited beliefs and strategies concerning how they complete pain intensity questionnaires are sometimes, but not invariably, reflected in their responses to these measures. Thus, purely qualitative methodologies alone cannot provide completely reliable information and point to the need to use a “mixed methods” approach combining both qualitative and quantitative data; (2) the lack of association between pain intensity measures and interference with activities of daily living, as well as relative insensitivity to different etiologies underlines the problem in relying on pain intensity measures as the primary means of evaluating the success of a treatment, either for pain management or in clinical research.
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Kersten, R. F. M. R., J. Fikkers, N. Wolterbeek, F. C. Öner, and S. M. van Gaalen. "Are the Roland Morris Disability Questionnaire and Oswestry Disability Index interchangeable in patients after lumbar spinal fusion?" Journal of Back and Musculoskeletal Rehabilitation 34, no. 4 (July 13, 2021): 605–11. http://dx.doi.org/10.3233/bmr-200206.
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BACKGROUND: Low back pain is a common health problem for which there are several treatment options. For optimizing clinical decision making, evaluation of treatments and research purposes it is important that health care professionals are able to evaluate the functional status of patients. Patient reported outcome measures (PROMs) are widely accepted and recommended. The Roland Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI) are the two mainly used condition-specific patient reported outcomes. Concerns regarding the content and structural validity and also the different scoring systems of these outcome measures makes comparison of treatment results difficult. OBJECTIVE: Aim of this study was to determine if the RMDQ and ODI could be used exchangeable by assessing the correlation and comparing different measurement properties between the questionnaires. METHODS: Clinical data from patients who participated in a multicenter RCT with 2 year follow-up after lumbar spinal fusion were used. Outcome measures were the RMDQ, ODI, Short Form 36 – Health Survey (SF-36), leg pain and back pain measured on a 0–100 mm visual analogue scale (VAS). Cronbach’s alpha coefficients, Spearman correlation coefficients, multiple regression analysis and Bland-Altman plots were calculated. RESULTS: three hundred and seventy-six completed questionnaires filled out by 87 patients were used. The ODI and RMDQ had both a good level of internal consistency. There was a very strong correlation between the RMDQ and the ODI (r= 0.87; p< 0.001), and between the VAS and both the ODI and RMDQ. However, the Bland-Altman plot indicated bad agreement between the ODI and RMDQ. CONCLUSIONS: The RMDQ and ODI cannot be used interchangeably, nor is there a possibility of converting the score from one questionnaire to the other. However, leg pain and back pain seemed to be predictors for both the ODI and the RMDQ.
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Rasmussen-Barr, Eva, Cecilia Lindqvist, Sara Östhols, and Carina Boström. "Are patient reported outcome measures (PROMs) useful in low back pain? Experiences of physiotherapists in primary health care in Sweden." Musculoskeletal Science and Practice 55 (October 2021): 102414. http://dx.doi.org/10.1016/j.msksp.2021.102414.
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Feldman, Ron, Yaniv Nudelman, Sharon Haleva-Amir, Tamar Pincus, and Noa Ben Ami. "Patients’ Perceptions and Outcome Measures after Undergoing the Enhanced Transtheoretical Model Intervention (ETMI) for Chronic Low Back Pain: A Mixed-Method Study." International Journal of Environmental Research and Public Health 19, no. 10 (May 17, 2022): 6106. http://dx.doi.org/10.3390/ijerph19106106.
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This study aimed to evaluate the outcome measures and perceptions of patients with chronic low back pain (CLBP) after being treated with the Enhanced Transtheoretical Model Intervention (ETMI). In this process evaluation mixed-methods study, 30 patients with CLBP electronically completed self-reported measures (function, pain, and fear-avoidance beliefs) before and after ETMI treatment. Subsequently, each patient participated in one-on-one, semi-structured interviews, which were audio-recorded, transcribed, coded, and analyzed thematically. Quantitative analysis showed significant improvements in function (p < 0.001), pain (p < 0.001), and fear-avoidance beliefs (p < 0.001) after receiving ETMI treatment, with a large effect size (Cohen’s d = 1.234). Moreover, the average number of physiotherapy sessions was 2.6 ± 0.6 for the ETMI intervention, while the annual average number in Maccabi is estimated at 4.1 ± 1.5. Three main themes emerged from the thematic analysis: (1) communication between the patient and the practitioner; (2) psychosocial treatment elements, and (3) ETMI as a long-term solution for CLBP. The findings of the current study highlight patients’ perceived need for an open and sincere dialogue and for receiving reassurance and encouragement about their LBP. Notably, they had no problem with the fact that they did not receive passive treatment. Accordingly, together with the significant improvement in post-treatment outcome measures, patients perceived the ETMI method as a practical tool for self-managing their back problems in the long term.
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Tosic, Lazar, Elior Goldberger, Nicolai Maldaner, Marketa Sosnova, Anna M. Zeitlberger, Victor E. Staartjes, Pravesh S. Gadjradj, et al. "Normative data of a smartphone app–based 6-minute walking test, test-retest reliability, and content validity with patient-reported outcome measures." Journal of Neurosurgery: Spine 33, no. 4 (October 2020): 480–89. http://dx.doi.org/10.3171/2020.3.spine2084.
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OBJECTIVEThe 6-minute walking test (6WT) is used to determine restrictions in a subject’s 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements.METHODSThe maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16–91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3–40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs.RESULTSThe ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87–0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7–597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001).CONCLUSIONSThis study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.
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Nijs, Jo. "Auto-Targeted Neurostimulation Is Not Superior to Placebo in Chronic Low Back Pain: A Fourfold Blind Randomized Clinical Trial." July 2016 5;19, no. 5;19 (July 14, 2016): E707—E719. http://dx.doi.org/10.36076/ppj/2019.19.e707.
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Background: Myofascial trigger points (MTrPs) are common in people with musculoskeletal pain and may play a role in chronic nonspecific low back pain (CLBP). One of the potential treatments of MTrPs is the Nervomatrix Soleve® auto-targeted neurostimulation device, providing targeted transcutaneous electrical nerve stimulation (TENS) to MTrPs in the lower back muscles. To date, no controlled studies have evaluated the effectiveness of this device for the pain management of this population. Objective: To examine whether the Nervomatrix Soleve® auto-targeted neurostimulation device is superior over placebo for the treatment of CLBP. Study Design: A fourfold-blind randomized controlled trial was conducted. Setting: Brussels University Hospital, health care centers and pharmacies around Belgium. Methods: Participants with CLBP for at least 3 months were randomly assigned to the experimental (the Nervomatrix Soleve® auto-targeted neurostimulation device providing TENS-stimulation and mechanical pressure) or placebo group (the Nervomatrix Soleve® autotargeted neurostimulation device providing mechanical pressure alone without current). The treatment protocol in both groups consisted of 6 treatment sessions per patient. Participants were evaluated at baseline prior to the intervention, immediately following treatment, and at one month follow-up. Pain and pain behavior (steps climbed) were assessed as primary outcome measures. Secondary outcome measures were pain functioning, health beliefs, symptoms of central sensitization, pain catastrophizing, and kinesiophobia. Results: In total, 39 participants were included in the study. Participants in both groups improved significantly for pain and functioning, but no significant differences were observed between groups. These improvements were not clinically meaningful for any of the reported measures. The health beliefs changed significantly in both groups (P < 0.05), with superior results at follow-up in the placebo group. Limitations: The follow-up period is limited to one month. Conclusions: Treatment of MTrPs with the Nervomatrix Soleve® auto-targeted neurostimulation device in patients with CLBP does not result in a better outcome than placebo-treatment in terms of pain, pain behavior, functioning, central sensitization, pain catastrophizing, and health beliefs. Key words: Low back pain, chronic pain, randomized controlled trial, electric stimulation therapy, trigger points
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Haladay, Douglas, Rebecca Edgeworth Ditwiler, Aimee B. Klein, Rebecca Miro, Matthew Lazinski, Laura Lee Swisher, Jason Beckstead, Jay Wolfson, and Dustin Hardwick. "Goal Attainment Scaling in Outpatient Physical Therapy for Chronic Low Back Pain: Protocol for a Mixed Methods Study." JMIR Research Protocols 11, no. 3 (March 7, 2022): e32457. http://dx.doi.org/10.2196/32457.
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Background Patient engagement in decisions regarding their health care may lead to improved outcomes and improved adherence to treatment plans. While there are several options for involving patients in their health care, goal setting is a readily accessible method for physical therapists to increase the involvement of patients in health care decisions. Physical therapy goals are often generated by health care providers based on subjective information or standardized, fixed-item, patient-reported outcome measures. However, these outcome measures may not fully reveal the activity and participation limitations of individual patients. Goal attainment scaling (GAS) is a patient-centered approach that allows patients to set meaningful goals. While GAS has been shown to be reliable, valid, and sensitive to change in various populations, there is limited evidence in the United States on utilizing GAS in physical therapy for patients with chronic low back pain (LBP). Objective The purpose of this paper is to describe the protocol for a study to (1) develop a way to apply GAS procedures for physical therapists treating patients with chronic LBP in the United States and (2) test the feasibility of applying GAS procedures for chronic LBP in an outpatient physical therapy setting. Methods This study used a mixed methods design with 2 phases: qualitative and quantitative. The qualitative phase of the study employed focus groups of patients with chronic LBP to identify an inventory of goals that were important and measurable. A series of prompts was developed from this inventory to assist physical therapists in collaboratively establishing goals with patients in a clinical setting. The quantitative phase of the study pilot-tested the inventory developed in the qualitative phase in patients with chronic LBP to determine feasibility, reliability, validity, and responsiveness. We also plan to compare how well GAS reveals change over time relative to traditional, fixed-item, patient-reported measures. Results Phase 1 data collection was completed in June 2020, while data collection for phase 2 was performed between March 2021 and December 2021. We anticipate that this study will demonstrate that GAS can be implemented successfully by outpatient physical therapists, and that it will demonstrate clinically important changes in patients with chronic LBP. Conclusions GAS represents an opportunity for patient-centered care in the physical therapy management of chronic LBP. While GAS is not new, it has never been studied in real-world physical therapy for chronic LBP in a clinical setting. Due to unique time and productivity constraints, for GAS to be successfully implemented in this environment, we must demonstrate that clinicians can be trained efficiently and reliably, that GAS can be implemented in a clinical setting in under 15 minutes, and that GAS is able to detect clinically meaningful changes in patient outcomes. International Registered Report Identifier (IRRID) DERR1-10.2196/32457
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McKeag, Philip, Niall Eames, Lynn Murphy, Raymond McKenna, Eilish Simpson, and Gillian Graham. "Assessment of the utility of the National Health Service England Low Back and Radicular Pain Pathway: analysis of patient reported outcomes." British Journal of Pain 14, no. 1 (May 13, 2019): 42–46. http://dx.doi.org/10.1177/2049463719846913.
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Introduction: Lumbar disc herniation causing radiculopathy is a common reason for referral to spinal out-patient clinics. At our centre following routine referral, patients wait a mean of 109 weeks for a consultation with a spinal surgeon. A pathway in keeping with the National Health Service England Low Back and Radicular Pain Pathway was introduced with two objectives. Patients would be seen sooner by suitably trained health care professionals to avoid long waiting times for assessment with a spinal surgeon, and if a set of criteria were met, they would receive a selective nerve root injection to manage their pain. Methods: Patients were seen by specially trained orthopaedic physiotherapists following routine general practitioner (GP) referral. A radiologically guided nerve root injection was carried out if patients had radicular pain between 6 and 52 weeks duration and a magnetic resonance imaging (MRI) scan demonstrating an intervertebral disc prolapse correlating with their radicular symptoms. Patient-recorded outcome measures were taken before and after nerve root injection. Results: Seventy five patients entered the pathway. Mean patient age was 49.9 years and 27 patients (36.0%) were male. Mean time from referral to assessment was 15.5 weeks. Mean visual analogue score (VAS) for leg pain was 7.4 out of 10 before nerve root injection and 4.8 out of 10 following nerve root injection (p < 0.001). Mean Oswestry Low Back Pain Disability Questionnaire score before nerve root injection was 58.4% and 49.7% following nerve root injection (p = 0.024). Mean Euroqol EQ-5D-5L Health Index was 0.2 before nerve root injection and 0.4 afterwards (p < 0.001). Conclusion: This study suggests that this pathway may help to reduce waiting times for patients with lumbar radiculopathy secondary to intervertebral disc prolapse. The resulting enhanced care may be associated with a reduction in leg and back pain and an improvement in quality of life.
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Wellburn, Shaun, Cormac G. Ryan, Andrew Coxon, Alastair J. Dickson, D. John Dickson, Francis Fatoye, Diarmaid Ferguson, et al. "Long-term improvements following a residential combined physical and psychological programme for chronic low back pain." BMJ Open Quality 10, no. 2 (May 2021): e001068. http://dx.doi.org/10.1136/bmjoq-2020-001068.
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ObjectivesEvaluate the outcomes and explore experiences of patients undergoing a residential combined physical and psychological programme (CPPP) for chronic low back pain.DesignA longitudinal observational cohort design, with a parallel qualitative design using semistructured interviews.SettingResidential, multimodal rehabilitation.Participants136 adults (62 male/74 female) referred to the CPPP, 100 (44 male/56 female) of whom completed the programme, during the term of the study. Ten (2 male/8 female) participated in the qualitative evaluation.InterventionA 3-week residential CPPP.Outcome measuresPrimary outcome measures were the STarT Back screening tool score; pain intensity—11-point Numerical Rating Scale; function—Oswestry Disability Index (ODI); health status/quality of life—EQ-5D-5L EuroQol five-Dimension-five level; anxiety—Generalised Anxiety Disorder-7; depression—Patient Health Questionnaire-9. Secondary outcome measures were the Global Subjective Outcome Scale; National Health Service Friends and Family Test;.ResultsAt discharge, 6 and 12 months follow ups, there were improvements from baseline that were greater than minimum clinically important differences in each of the outcomes (with the sole exception of ODI at discharge). At 12 months, the majority of people considered themselves a lot better (57%) and were extremely likely (86%) to recommend the programme to a friend. The qualitative data showed praise for the residential nature of the intervention and the opportunities for interaction with peers and peer support. There were testimonies of improvements in understanding of pain and how to manage it better. Some participants said they had reduced, or stopped, medication they had been taking to manage their pain.ConclusionsParticipants improved, and maintained long term, beyond minimum clinically important differences on a wide range of outcomes. Participants reported an enhanced ability to self-manage their back pain and support for the residential setting.
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Froud, Robert, Carol Fawkes, Jonathan Foss, Martin Underwood, and Dawn Carnes. "Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study." Journal of Medical Internet Research 20, no. 10 (October 24, 2018): e272. http://dx.doi.org/10.2196/jmir.9828.
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Beneciuk, Jason M., Mark D. Bishop, Julie M. Fritz, Michael E. Robinson, Nabih R. Asal, Anne N. Nisenzon, and Steven Z. George. "The STarT Back Screening Tool and Individual Psychological Measures: Evaluation of Prognostic Capabilities for Low Back Pain Clinical Outcomes in Outpatient Physical Therapy Settings." Physical Therapy 93, no. 3 (March 1, 2013): 321–33. http://dx.doi.org/10.2522/ptj.20120207.
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BackgroundPsychologically informed practice emphasizes routine identification of modifiable psychological risk factors being highlighted.ObjectiveThe purpose of this study was to test the predictive validity of the STarT Back Screening Tool (SBT) in comparison with single-construct psychological measures for 6-month clinical outcomes.DesignThis was an observational, prospective cohort study.MethodsPatients (n=146) receiving physical therapy for low back pain were administered the SBT and a battery of psychological measures (Fear-Avoidance Beliefs Questionnaire physical activity scale and work scale [FABQ-PA and FABQ-W, respectively], Pain Catastrophizing Scale [PCS], 11-item version of the Tampa Scale of Kinesiophobia [TSK-11], and 9-item Patient Health Questionnaire [PHQ-9]) at initial evaluation and 4 weeks later. Treatment was at the physical therapist's discretion. Clinical outcomes consisted of pain intensity and self-reported disability. Prediction of 6-month clinical outcomes was assessed for intake SBT and psychological measure scores using multiple regression models while controlling for other prognostic variables. In addition, the predictive capabilities of intake to 4-week changes in SBT and psychological measure scores for 6-month clinical outcomes were assessed.ResultsIntake pain intensity scores (β=.39 to .45) and disability scores (β=.47 to .60) were the strongest predictors in all final regression models, explaining 22% and 24% and 43% and 48% of the variance for the respective clinical outcome at 6 months. Neither SBT nor psychological measure scores improved prediction of 6-month pain intensity. The SBT overall scores (β=.22) and SBT psychosocial scores (β=.25) added to the prediction of disability at 6 months. Four-week changes in TSK-11 scores (β=−.18) were predictive of pain intensity at 6 months. Four-week changes in FABQ-PA scores (β=−.21), TSK-11 scores (β=−.20) and SBT overall scores (β=−.18) were predictive of disability at 6 months.LimitationsPhysical therapy treatment was not standardized or accounted for in the analysis.ConclusionsPrediction of clinical outcomes by psychology-based measures was dependent upon the clinical outcome domain of interest. Similar to studies from the primary care setting, initial screening with the SBT provided additional prognostic information for 6-month disability and changes in SBT overall scores may provide important clinical decision-making information for treatment monitoring.
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Andersen, Mikkel Østerheden, Peter Fritzell, Søren Peter Eiskjaer, Tobias Lagerbäck, Olle Hägg, Dennis Nordvall, Greger Lönne, et al. "Surgical Treatment of Degenerative Disk Disease in Three Scandinavian Countries: An International Register Study Based on Three Merged National Spine Registers." Global Spine Journal 9, no. 8 (March 25, 2019): 850–58. http://dx.doi.org/10.1177/2192568219838535.
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Study Design: Observational study of prospectively collected data. Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets. Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries. Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain. Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.
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Gardiner, Sara, Helena Daniell, Benjamin Smith, and Rachel Chester. "Are stabilisation exercises different to other treatments in improving physical activity or reducing disability for people with persistent low back pain? A systematic literature review." International Journal of Therapy and Rehabilitation 27, no. 11 (November 2, 2020): 1–16. http://dx.doi.org/10.12968/ijtr.2019.0109.
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Background/Aims Stabilisation exercises are commonly prescribed for people with persistent low back pain. However, for some patients, it has been hypothesised that stabilisation exercises could draw attention to protecting the core, promote hypervigilance and inhibit volitional movement. The aim of this study was to compare the effectiveness and reported adverse events, in particular fear avoidance, of stabilisation exercises compared with placebo or other treatments offered by physiotherapists on the outcome of disability and activity at 12- and 24-months' follow-up. Methods The following electronic databases were searched: Embase, Medline, AMED, CINAHL, from inception to June 2019. Only randomised controlled trails were included. Study selection, data extraction and appraisal of quality criteria using PEDro, were undertaken by two independent assessors. Results Seven studies (n=1820) were eligible. Of six studies that reported adverse effects in the group receiving stabilisation exercises, four reported none and two reported mild exacerbation of pain locally or elsewhere. Fear avoidance was not investigated in any of the studies. Across the studies, 12 analyses were reported and included seven different comparator groups and three outcome measures: Oswestry Disability Index (n=1), Roland Morris Disability Questionnaire (n=5), Patient Specific Functional Scale (n=4). Two studies included a 24-month follow up in addition to a 12-month follow up. Of the 12 studies, nine reported no significant differences between the effectiveness of stabilisation exercises and comparator groups. Stabilisation exercises were more effective than comparator groups for the following three analyses: compared to manual therapy or education at 12 but not 24 months for the Oswestry Disability Index (15.71, 95% confidence interval 19.3–10.01); compared to placebo for the Patient Specific Functional Scale (1.5, 95% confidence interval 0.7–2.2) but not the Roland Morris Disability Questionnaire; and compared to high load lifting for the Patient Specific Functional Scale (1.8 95% confidence interval 2.8–0.7). Conclusions Stabilisation exercises are safe and equally effective to other treatments, and possibly superior for some outcomes at some time points. No or only mild adverse effects were reported. However, none of the studies measured fear avoidance as an outcome and we recommend this be included in future randomised controlled trials measuring the effectiveness of stabilisation exercises.
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Dutmer, Alisa L., Remko Soer, André P. Wolff, Michiel F. Reneman, Maarten H. Coppes, and Henrica R. Schiphorst Preuper. "What can we learn from long-term studies on chronic low back pain? A scoping review." European Spine Journal 31, no. 4 (January 19, 2022): 901–16. http://dx.doi.org/10.1007/s00586-022-07111-3.
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Abstract Purpose A scoping review was conducted with the objective to identify and map the available evidence from long-term studies on chronic non-specific low back pain (LBP), to examine how these studies are conducted, and to address potential knowledge gaps. Method We searched MEDLINE and EMBASE up to march 2021, not restricted by date or language. Experimental and observational study types were included. Inclusion criteria were: participants between 18 and 65 years old with non-specific sub-acute or chronic LBP, minimum average follow-up of > 2 years, and studies had to report at least one of the following outcome measures: disability, quality of life, work participation, or health care utilization. Methodological quality was assessed using the Effective Public Health Practice Project quality assessment. Data were extracted, tabulated, and reported thematically. Results Ninety studies met the inclusion criteria. Studies examined invasive treatments (72%), conservative (21%), or a comparison of both (7%). No natural cohorts were included. Methodological quality was weak (16% of studies), moderate (63%), or strong (21%) and generally improved after 2010. Disability (92%) and pain (86%) outcomes were most commonly reported, followed by work (25%), quality of life (15%), and health care utilization (4%). Most studies reported significant improvement at long-term follow-up (median 51 months, range 26 months–18 years). Only 10 (11%) studies took more than one measurement > 2 year after baseline. Conclusion Patients with persistent non-specific LBP seem to experience improvement in pain, disability and quality of life years after seeking treatment. However, it remains unclear what factors might have influenced these improvements, and whether they are treatment-related. Studies varied greatly in design, patient population, and methods of data collection. There is still little insight into the long-term natural course of LBP. Additionally, few studies perform repeated measurements during long-term follow-up or report on patient-centered outcomes other than pain or disability.
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Habenicht, Richard, Elisabeth Fehrmann, Peter Blohm, Gerold Ebenbichler, Linda Fischer-Grote, Josef Kollmitzer, Patrick Mair, and Thomas Kienbacher. "Machine Learning Based Linking of Patient Reported Outcome Measures to WHO International Classification of Functioning, Disability, and Health Activity/Participation Categories." Journal of Clinical Medicine 12, no. 17 (August 28, 2023): 5609. http://dx.doi.org/10.3390/jcm12175609.
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Background: In the primary and secondary medical health sector, patient reported outcome measures (PROMs) are widely used to assess a patient’s disease-related functional health state. However, the World Health Organization (WHO), in its recently adopted resolution on “strengthening rehabilitation in all health systems”, encourages that all health sectors, not only the rehabilitation sector, classify a patient’s functioning and health state according to the International Classification of Functioning, Disability and Health (ICF). Aim: This research sought to optimize machine learning (ML) methods that fully and automatically link information collected from PROMs in persons with unspecific chronic low back pain (cLBP) to limitations in activities and restrictions in participation that are listed in the WHO core set categories for LBP. The study also aimed to identify the minimal set of PROMs necessary for linking without compromising performance. Methods: A total of 806 patients with cLBP completed a comprehensive set of validated PROMs and were interviewed by clinical psychologists who assessed patients’ performance in activity limitations and restrictions in participation according to the ICF brief core set for low back pain (LBP). The information collected was then utilized to further develop random forest (RF) methods that classified the presence or absence of a problem within each of the activity participation ICF categories of the ICF core set for LBP. Further analyses identified those PROM items relevant to the linking process and validated the respective linking performance that utilized a minimal subset of items. Results: Compared to a recently developed ML linking method, receiver operating characteristic curve (ROC-AUC) values for the novel RF methods showed overall improved performance, with AUC values ranging from 0.73 for the ICF category d850 to 0.81 for the ICF category d540. Variable importance measurements revealed that minimal subsets of either 24 or 15 important PROM variables (out of 80 items included in full set of PROMs) would show similar linking performance. Conclusions: Findings suggest that our optimized ML based methods more accurately predict the presence or absence of limitations and restrictions listed in ICF core categories for cLBP. In addition, this accurate performance would not suffer if the list of PROM items was reduced to a minimum of 15 out of 80 items assessed.
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Hale, MD, Martin E., Yuju Ma, MS, and Richard Malamut, MD. "Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential." Journal of Opioid Management 12, no. 2 (March 1, 2016): 139. http://dx.doi.org/10.5055/jom.2016.0326.
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Objective: To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology.Design: Phase 3, multicenter, open-label extension.Setting: Fifty-six US centers.Patients: Adults with chronic low back pain completing a 12-week placebo-controlled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥1 dose of study drug, 170 entered open-label treatment, and 136 completed the study.Interventions: Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n = 78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment.Main outcome measures: Safety: adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. Results: AEs were reported for 65/182 (36 percent) patients during dose titration/adjustment and 88/170 (52 percent) during open-label treatment. No treatment-related serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion.Conclusions: Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.
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Schröder, Karin, Birgitta Öberg, Paul Enthoven, Henrik Hedevik, Maria Fors, and Allan Abbott. "Effectiveness and Quality of Implementing a Best Practice Model of Care for Low Back Pain (BetterBack) Compared with Routine Care in Physiotherapy: A Hybrid Type 2 Trial." Journal of Clinical Medicine 10, no. 6 (March 16, 2021): 1230. http://dx.doi.org/10.3390/jcm10061230.
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Low back pain (LBP) occurs in all ages and first-line treatment by physiotherapists is common. The main aim of the current study was to evaluate the effectiveness of implementing a best practice model of care for LBP (intervention group—BetterBack☺ MoC) compared to routine physiotherapy care (control group) regarding longitudinal patient reported outcomes. The BetterBack☺ MoC contains clinical guideline recommendations and support tools to facilitate clinician adherence to guidelines. A secondary exploratory aim was to compare patient outcomes based on the fidelity of fulfilling a clinical practice quality index regarding physiotherapist care. A stepped cluster randomized design nested patients with LBP in the three clusters which were allocated to control (n = 203) or intervention (n = 264). Patient reported measures were collected at baseline, 3, 6 and 12 months and analyzed with mixed model regression. The primary outcome was between-group changes from baseline to 3 months for pain intensity and disability. Implementation of the BetterBack☺ MoC did not show any between-group differences in the primary outcomes compared with routine care. However, the intervention group showed significantly higher satisfaction at 3 months and clinically meaningful greater improvement in LBP illness perception at 3 months and quality of life at 3 and 6 months but not in patient enablement and global impression of change compared with the control group. Physiotherapists’ care that adhered to all clinical practice quality indices resulted in an improvement of most patient reported outcomes with a clinically meaningful greater improved LBP illness perception at 3 months and quality of life at 3 and 6 months, significantly greater improvement in LBP illness perception, pain and satisfaction at 3 and 6 months and significantly better enablement at all time points as well as better global improvement outcomes at 3 months compared with non-adherent care. This highlights the importance of clinical guideline based primary care for improving patient reported LBP outcomes.
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Fields, Aaron J., Alexander Ballatori, Misung Han, Jeannie F. Bailey, Zachary L. McCormick, Conor W. O’Neill, Sibel Demir-Deviren, Roland Krug, and Jeffrey C. Lotz. "Measurement of vertebral endplate bone marrow lesion (Modic change) composition with water–fat MRI and relationship to patient-reported outcome measures." European Spine Journal 30, no. 9 (February 6, 2021): 2549–56. http://dx.doi.org/10.1007/s00586-021-06738-y.
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Abstract Purpose Vertebral endplate bone marrow lesions (“Modic changes”, MC) are associated with chronic low back pain (CLBP). Bone marrow composition in MC is poorly understood. The goals of this study were to: (1) measure bone marrow fat fraction (BMF) in CLBP patients with MC using water–fat MRI and (2) assess the relationship between BMF measurements and patient-reported clinical characteristics. Methods In this cross-sectional study, 42 CLBP patients (men, n = 21; age, 48 ± 12.4 years) and 18 asymptomatic controls (men, n = 10; 42.7 ± 12.8 years) underwent 3 T MRI between January 2016 and July 2018. Imaging consisted of T1- and T2-weighted sequences to evaluate MC and spoiled gradient-recalled echo sequence with asymmetric echoes and least-squares fitting to measure BMF. BMF was compared between vertebrae with and without MC using mixed effects models. The relationship between the BMF measurements and patient-reported disability scores was examined using regression. Results Twenty-seven subjects (26 CLBP, 1 control) had MC, and MC presence coincided with significantly altered BMF. In MC 1, BMF was lower than endplates without MC (absolute difference −22.3%; p < 0.001); in MC 2, BMF was higher (absolute difference 21.0%; p < 0.001). Absolute BMF differences between affected and unaffected marrow were larger in patients with greater disability (p = 0.029–0.032) and were not associated with pain (p = 0.49–0.83). Conclusion BMF is significantly altered in MC. Water–fat MRI enables BMF measurements that may eventually form the basis for quantitative assessments of MC severity and progression.
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Chiarotto, Alessandro, Raymond W. Ostelo, Maarten Boers, and Caroline B. Terwee. "A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain." Journal of Clinical Epidemiology 95 (March 2018): 73–93. http://dx.doi.org/10.1016/j.jclinepi.2017.11.005.
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Yakovlev, Alexander. "Outcomes of Percutaneous Disc Decompression Utilizing Nucleoplasty for the Treatment of Chronic Discogenic Pain." Pain Physician 2;10, no. 3;2 (March 14, 2007): 319–27. http://dx.doi.org/10.36076/ppj.2007/10/319.
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Background: Percutaneous disc decompression utilizing Nucleoplasty has emerged as one of the minimally invasive techniques for treatment of low back pain and lower extremity pain due to contained herniated discs. Only 1 study to date has examined its effect on functional activity and pain medication use; however, results were not analyzed over time, and recall bias was a limitation. Objective: Evaluation of the effect of Nucleoplasty on pain and opioid use in improving functional activity in patients with radicular or axial low back pain secondary to contained herniated discs. Design: Retrospective, non-randomized case series. Methods: Twenty-two patients who had undergone Nucleoplasty were included in the analysis. Patients were evaluated at 1, 3, 6, and 12 months postoperatively, and were asked to quantify their pain using a visual analog scale ranging from 0 to 10. Patients were also surveyed in regards to their pain medication use, and functional status was quantified by a physical therapist who also used patient reports of ability to perform activities of daily living to assess status. Data were compared between baseline and at 1, 3, 6, and 12 months posttreatment. Results: Reported pain and medication use were significantly decreased and functional status was improved at 1, 3, 6, and 12 months following Nucleoplasty (P values ≤ 0.0010 for all outcome measures at all time periods). There were no complications associated with the procedure and we found continued improvements over time. Conclusion: Nucleoplasty appears to be safe and effective. Randomized, controlled studies are required to further evaluate its long-term efficacy. Key words: Discectomy, disc herniation, low back pain, minimally invasive, Nucleoplasty, percutaneous disc decompression.
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Gladwell, Peter William, Kathryn Badlan, Fiona Cramp, and Shea Palmer. "Direct and Indirect Benefits Reported by Users of Transcutaneous Electrical Nerve Stimulation for Chronic Musculoskeletal Pain: Qualitative Exploration Using Patient Interviews." Physical Therapy 95, no. 11 (November 1, 2015): 1518–28. http://dx.doi.org/10.2522/ptj.20140120.
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Background There is no consensus regarding the effectiveness of transcutaneous electrical nerve stimulation (TENS) for management of chronic musculoskeletal pain or chronic low back pain. A recent review of previous trial methodology identified significant problems with low treatment fidelity. There is little information available to guide selection of patient-reported outcome measures appropriate for TENS evaluation. Objectives The purpose of this study was to explore the experiences of patients at a secondary care pain clinic who successfully used TENS to help manage chronic musculoskeletal pain. These key informants were selected because they had the potential to generate knowledge that could inform research design and clinical practice. Design A qualitative method using individual semistructured interviews with open questions was selected for its capacity to generate rich data. Methods A mini focus group informed the development of a discussion guide for semistructured interviews with 9 patients (6 women, 3 men). Thematic analysis was used as the primary data analysis method, and this analysis was enhanced by a case-level analysis of the context and processes of TENS use of each individual. Results Data analysis indicated that distraction from pain and a reduction in the sensations associated with muscle tension or spasm should be considered as separate outcomes from pain relief. These direct benefits led to a wide range of indirect benefits dependent on patient decision making, including medication reduction, enhanced function, psychological benefits, and enhanced ability to rest. Conclusions The findings indicate that evaluating TENS using a unidimensional pain scale is likely to overlook potential benefits. The complex pattern of TENS usage, as well as multiple direct and indirect outcomes, indicates that TENS could be considered as a complex intervention.
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Kim, Song-Yi, Hyejung Lee, Hyangsook Lee, Ji-Yeun Park, Sang Kyun Park, and Hi-Joon Park. "An Observational Study on the Costs and Consequences of Acupuncture for the Management of Chronic Low Back Pain in Korean Patients." Acupuncture in Medicine 33, no. 2 (April 2015): 148–53. http://dx.doi.org/10.1136/acupmed-2014-010641.
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Objectives To investigate the consequences and costs of acupuncture in general medical practice for patients with chronic low back pain (CLBP) in Korea. Methods A multicentre observational study was performed. Outpatients with CLBP who received at least one acupuncture session in a Korean Medicine clinic during the study period were included and followed up for 3 months. All patients received regular acupuncture treatments in accordance with the doctors’ discretion. The consequences in terms of effects included condition-specific outcomes and preference-based outcome. For cost analysis, the cumulative resource use for direct medical costs at each research clinic during the study period and direct patient data using the self-reported healthcare utilisation questionnaires were used. Results A total of 157 patients were eligible to participate and 105 were finally included. Significant improvements in condition-specific and preference-based measures were observed after acupuncture treatment. An average of approximately $146 (£93) per patient was reported for direct medical costs in each clinic for 1 month and $231 (£148) for 3 months. Other medical expenses related to CLBP were reduced during this period. Conclusions The use of acupuncture to manage CLBP in general clinical practice in Korea inexpensively improved pain, functional disability and quality of life. The study results are meaningful and consistent with the results of previous trials performed in other European countries but the power of the study is not strong, having major design weaknesses. A large-scale cohort or registry based on practice may be helpful to strengthen the evidence of the cost-effectiveness of acupuncture.
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Parker, Scott L., and Matthew J. McGirt. "Determination of the Minimum Improvement in Pain, Disability, and Health State Associated With Cost-Effectiveness." Neurosurgery 71, no. 6 (September 14, 2012): 1149–55. http://dx.doi.org/10.1227/neu.0b013e318271ebde.
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ABSTRACT BACKGROUND: Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients. OBJECTIVE: To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED). METHODS: Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50 000/QALY and < $75 000/QALY. MCID was determined with the health transition item as the anchor. RESULTS: Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42 854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43 560 vs $112 087), visual analog scale for back pain ($41 280 vs $129 440), Oswestry Disability Index ($30 954 vs $121 750), and EuroQol 5D ($35 800 vs $189 412). CONCLUSION: MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50 000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.
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Rolving, Nanna, Karina Agerbo, Stine Aalkjær Clausen, Kate Ane Rauff Denby, Anna Puk Jacobsen, and Vivian Langagergaard. "Does group-based cognitive therapy improve functional ability, pain, catastrophic thoughts and quality of life in patients with persistent low back pain and psychological risk factors? A randomised controlled trial in a secondary care setting." Clinical Rehabilitation 36, no. 3 (December 30, 2021): 317–30. http://dx.doi.org/10.1177/02692155211056202.
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Objective To investigate the effects of a group-based cognitive behavioural intervention for patients with persistent low back pain (LBP) and psychological risk factors referred to secondary care. Design A randomised controlled trial. Setting Silkeborg Regional Hospital, Denmark. Subjects A total of 136 participants with chronic LBP and psychological risk factors. Interventions Participants were randomised to the standard care group, including examination by a rheumatologist and/or a physiotherapist, or the intervention group, including standard care plus a multidisciplinary group-based pain management programme. Main measures Patient-reported outcomes were collected at baseline and after 6 and 12 months. The primary outcome was disability (Roland Morris Disability Questionnaire). Secondary outcomes included low back pain intensity, pain catastrophising, health-related quality of life, and sick leave. Results Among 136 participants, 68 (mean age: 41.7 years (SD 11.8)) were randomised to standard care and 68 (mean age: 46.0 years (SD 10.8)) were randomised to the intervention group. Except for age, baseline characteristics were comparable between groups. 12-month follow-up was completed by 92.6% in the intervention group and 80.9% in the standard care group. Both groups achieved significant improvements on disability, with a reduction of −4.8 points (SD 6.1) in the intervention group compared to −3.7 points (SD 5.2), resulting in an insignificant difference between groups. No significant differences were found in the secondary outcomes. Conclusion A group-based pain management programme was no more effective than standard care for patients with persistent LBP and psychological risk factors.
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Russo, Dr Marc A. "High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience." Pain Physician 4;19, no. 4;5 (May 14, 2016): 267–80. http://dx.doi.org/10.36076/ppj/2019.19.267.
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Background: High frequency spinal cord stimulation at 10 kHz (HF10 therapy) represents a prominent advance in spinal cord stimulation (SCS) therapy, having demonstrated enhanced efficacy in patients with back and leg pain and pain relief without paresthesia that is sustained at 24 months post implant. Objective: To report on the effectiveness HF10 SCS therapy for a wide range of intractable pain conditions in clinical practice. Study Design: Retrospective investigation of 256 patients who trialed HF10 SCS for chronic intractable pain of various etiologies. Setting: Three Australian pain clinics. Methods: Two hundred fifty-six patients trialed HF10 SCS with view of a permanent implant if successful. Pain distributions included back + leg, back only, head ± neck, and neck ± arm/ shoulder. About 30% of patients had previously failed traditional low-frequency paresthesiabased stimulation, while the remaining cohort were either highly refractory to treatment or not recommended by the pain physician for traditional SCS. Pain scores (numerical pain rating scale – NPRS) and functional outcome measures (Oswestry Disability Index – ODI; and activity tolerance times) were assessed at baseline, post-trial, and at 3 and 6 months post-implant as available in the medical records. Results: Of the 256 patients, 189 (73%) reported a positive trial and were implanted. Patients with back + leg pain demonstrated the highest trial success rate (81%). A mean reduction in pain, among those for whom data were available, of 50% was sustained up to 6 months postimplant across the entire patient population. Sixty-eight percent of patients who failed traditional SCS reported a positive trial and mean pain relief at 6 months was 49% (P < 0.001). An 8.6 point reduction in ODI (21%) at 6 months and improved sitting, standing, and walking tolerances were also reported. Limitations: As data was collected retrospectively, missing data points were unavoidable; this was primarily due to inconsistent data collection and patients being lost to follow-up. Patient populations were diverse and a control group was not appropriate in this setting. Conclusions: These retrospective results demonstrate a significant advancement for patients suffering with chronic intractable pain and are consistent with recently published clinical results for HF10 SCS. HF10 SCS appears to be a viable, paresthesia-free alternative to traditional SCS, with high trial success rates, demonstrated effectiveness in a range of pain distributions including those typically difficult to treat with traditional SCS, and the possibility to restore pain control in patients who have previously failed traditional SCS. Key words: Spinal cord stimulation, high frequency stimulation, HF10, paresthesia-free stimulation, back pain, leg pain, cervical pain, neuromodulation
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Schmidt, Anne Mette, Berit Schiøttz-Christensen, Nadine E. Foster, Trine Bay Laurberg, and Thomas Maribo. "The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial." Clinical Rehabilitation 34, no. 3 (January 8, 2020): 382–93. http://dx.doi.org/10.1177/0269215519897968.
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Objective: To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain. Design: A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio). Setting: A rheumatology inpatient rehabilitation centre in Denmark. Subjects: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. Interventions: An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay. Main measures: Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed. Results: A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was −0.28 (95% confidence interval (CI): −4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes. Conclusion: An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.
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Park, Dr Chan Hong. "Dural Sac Cross-Sectional Area Does Not Correlate with Efficacy of Percutaneous Adhesiolysis in Single Level Lumbar Spinal Stenosis." Pain Physician 4;14, no. 4;7 (July 14, 2011): 277–82. http://dx.doi.org/10.36076/ppj.2011/14/377.
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Background: Spinal stenosis is a narrowing of the spinal canal, which causes mechanical compression of spinal nerve roots. The compression of these nerve roots can cause low back pain and/or leg pain, as well as neurogenic claudication. Lumbar epidural steroid injections have commonly been used in patients with lumbar spinal stenosis (LSS). In cases that are refractory to epidural steroid injections, percutaneous epidural adhesiolysis has been used. Objective: The aim of our study is to determine the relationship between the severity of spinal stenosis and the participants’ response to adhesiolysis, and to evaluate the mid-term effectiveness of adhesiolysis. Study Design: A prospective observational study. Methods: Sixty-six patients with degenerative LSS were enrolled in this prospective study. All participants underwent lumbar spine magnetic resonance imaging (MRI). The cross-sectional area of the dural sac was measured on the transverse angled sections through the central part of the disc on conventional MR images. All percutaneous adhesiolyses were performed in the operating room. One hour following the procedure, 6 mL of 8% sodium chloride solution was infused during 30 minutes in the recovery room while the patient underwent monitoring. Outcome measures were obtained using the 5-point patient satisfaction scale at 2 weeks and 6 months post-treatment. To evaluate outcome predictors, we divided the participants into 2 groups according to their response to treatment. Limitations: Secondary outcomes were not measured and the study did not include a long-term follow-up period. Results: Improvement (including reports of slightly improved, much improved, and no pain) was observed in 49 participants (74.2%) at 2 weeks and 45 participants (66.7%) at 6 months after the procedure. The dural sac cross-sectional area (DSCSA) did not differ between participants who reported improvement and those who did not. There was no statistically significant correlation between pain relief and DSCSA, age, or participant sex. Conclusion: Percutaneous adhesiolysis was shown to be effective for the treatment of LSS, with mid-term result, without affecting DSCSA. Key words: Low back pain, lumbar spinal stenosis, failed back surgery syndrome, dural sac, interventional techniques, epidural injection, percutaneous adhesiolysis.
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Hall, Amanda M., Paulo H. Ferreira, Christopher G. Maher, Jane Latimer, and Manuela L. Ferreira. "The Influence of the Therapist-Patient Relationship on Treatment Outcome in Physical Rehabilitation: A Systematic Review." Physical Therapy 90, no. 8 (August 1, 2010): 1099–110. http://dx.doi.org/10.2522/ptj.20090245.
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Background The working alliance, or collaborative bond, between client and psychotherapist has been found to be related to outcome in psychotherapy. Purpose The purpose of this study was to investigate whether the working alliance is related to outcome in physical rehabilitation settings. Data Sources A sensitive search of 6 databases identified a total of 1,600 titles. Study Selection Prospective studies of patients undergoing physical rehabilitation were selected for this systematic review. Data Extraction For each included study, descriptive data regarding participants, interventions, and measures of alliance and outcome—as well as correlation data for alliance and outcomes—were extracted. Data Synthesis Thirteen studies including patients with brain injury, musculoskeletal conditions, cardiac conditions, or multiple pathologies were retrieved. Various outcomes were measured, including pain, disability, quality of life, depression, adherence, and satisfaction with treatment. The alliance was most commonly measured with the Working Alliance Inventory, which was rated by both patient and therapist during the third or fourth treatment session. The results indicate that the alliance is positively associated with: (1) treatment adherence in patients with brain injury and patients with multiple pathologies seeking physical therapy, (2) depressive symptoms in patients with cardiac conditions and those with brain injury, (3) treatment satisfaction in patients with musculoskeletal conditions, and (4) physical function in geriatric patients and those with chronic low back pain. Limitations Among homogenous studies, there were insufficient reported data to allow pooling of results. Conclusions From this review, the alliance between therapist and patient appears to have a positive effect on treatment outcome in physical rehabilitation settings; however, more research is needed to determine the strength of this association.
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Bhat P, Vignesh, Vivek Dineshbhai Patel, Charu Eapen, Manisha Shenoy, and Steve Milanese. "Myofascial release versus Mulligan sustained natural apophyseal glides’ immediate and short-term effects on pain, function, and mobility in non-specific low back pain." PeerJ 9 (March 15, 2021): e10706. http://dx.doi.org/10.7717/peerj.10706.
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Background Myofascial release (MFR) and Mulligan Sustained Natural Apophyseal Glides (SNAGs) are manual therapy techniques routinely practiced in the management of non-specific low back pain (NSLBP). As a solo intervention or along with other therapies, both methods have reported positive results for individuals with NSLBP. However, which technique improves NSLBP-related pain, restricted range of motion (ROM) and disability, warrants further research. Objective To study the comparative effects of MFR and SNAGs on pain, disability, functional ability, and lumbar ROM in NSLBP. Method A parallel-group study was conducted at tertiary care hospitals. Sixty-five Sub-acute or chronic NSLBP patients were allocated to receive strengthening exercises along with either MFR (n = 33) or SNAGs (n = 32) for six treatment sessions over one week. An independent assessor evaluated outcome measures such as the Visual Analog Scale (VAS), Patient-Specific Function Scale (PSFS), and ROM at baseline, immediate (after 1st treatment), and short-term (post-sixth day of the intervention). The Modified Oswestry disability index (MODI) was assessed at baseline and short-term. Results Within-group analysis found clinically and statistically significant (p < 0.05) changes for VAS and PSFS at immediate and short-term for both the groups. The lumbar extension also showed improvement immediately and in the short-term. Improvement in Lumbar flexion was seen only in the SNAGs group over the short-term. A statistically significant improvement was seen for MODI in both the groups but was not clinically significant in the MFR group. The analysis observed no statistically significant difference (p < 0.05) between the groups at both the immediate and short-term. Conclusions Pain and restricted function associated with NSLBP can be improved using SNAGs or MFR, along with strengthening exercises. For limited lumbar flexion ROM, Mulligan SNAGs have a better outcome than MFR over the short-term. Hence, both manual therapy techniques can be incorporated along with exercises for immediate and short-term management of sub-acute to chronic NSLBP. Clinical Trial Registration. CTRI/2018/12/016787 (http://ctri.nic.in/Clinicaltrials/).
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Nyström, Bo, Henrik Weber, Birgitta Schillberg, and Adam Taube. "Symptoms and signs possibly indicating segmental, discogenic pain. A fusion study with 18 years of follow-up." Scandinavian Journal of Pain 16, no. 1 (July 1, 2017): 213–20. http://dx.doi.org/10.1016/j.sjpain.2016.10.007.
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AbstractBackgroundOnly two out of the five existing randomized studies have reported better results from fusion surgery for chronic low back pain (CLBP) compared to conservative treatment. In these studies the back symptoms of the patients were described simply as “chronic low back pain”. One possible reason for the modest results of surgery is the lack of a description of specified symptoms that might be related to a painful segment/disc, and patient selection may therefore be more or less a matter of chance. Previous prospective studies including facet joint injections and discography and eventually MRI have failed to identify patients with a painful segment/disc that will benefit from fusion surgery.PurposeOur purpose was to analyse in detail the pre-operative symptoms and signs presented by patients who showed substantial relief from their back pain following spinal fusion surgery with the aim of possibly finding a pain pattern indicating segmental, discogenic pain.MethodsWe analysed 40 consecutive patients, mean age 41 years, with a history of disabling low back pain for a mean of 7.7 years. Before surgery the patients completed a detailed questionnaire concerning various aspects of their back pain, and findings at clinical examination were thoroughly noted. Monosegmental posterior lumbar interbody fusion without internal fixation was performed using microsurgical technique. Outcome was assessed at 1, 2 and 4 years after surgery and finally at 18 years, using selfreporting measures and assessment by an independent examiner. Assessment at 18 years applied the Balanced Inventory for Spinal Disorders Questionnaire and the Roland-Morris Disability Questionnaire.ResultsAccording to the independent observer’s assessment at two years 27 of the 40 patients were much improved. Analysis of the pre-operative depiction of the back symptoms of this group revealed a rather uniform pattern, the most important being: dominating back pain originating in the midline of the spine, with a dull, aching character and stabbing pain in the same area provoked by sudden movements. Most patients in this group also had diffuse pain radiation of various extension down one or both legs and often bladder dysfunction with frequency. At clinical examination, localized interspinal tenderness was observed within the spinal area in question and the patient’s back pain was provoked by pressure in that area and by tapping a neighbouring spinous process.At 18 years after surgery 19 patients assessed themselves as much improved. At that time 5 of them had pension due to age, 7 early pension, one worked full time and six patients part time. Eleven patients were re-operated due to defect bony healing.ConclusionsThe results may suggest that the use of a detailed symptom analysis and clinical examination may make it possible to select a subgroup of patients within the CLBP group likely to have better outcome following fusion surgery.ImplicationsThe next step would be to execute prospective studies and if our findings concerning back pain details and signs among CLPB patients can be confirmed this can provide for more accurate selection of patients suitable for fusion surgery.
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Garcia, Laura, Brandon Birckhead, Parthasarathy Krishnamurthy, Ian Mackey, Josh Sackman, Vafi Salmasi, Robert Louis, et al. "Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: Follow-up Study of a Randomized Clinical Trial." Journal of Medical Internet Research 24, no. 5 (May 25, 2022): e37480. http://dx.doi.org/10.2196/37480.
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Background We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Conclusions Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Trial Registration ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID) RR2-10.2196/25291
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Sheetal, Mundhada, Mundhada Preeti, Khandelwal Rekha, Shrivastava Divya, Mundhada Ashutosh, and Raje Dhananjay. "Telerehabilitation for musculoskeletal disorders during the COVID-19 pandemic." International Journal of Physiotherapy and Research 9, no. 1 (February 11, 2021): 3765–72. http://dx.doi.org/10.16965/ijpr.2021.106.
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Aim: To evaluate the clinical effectiveness of telerehabilitation for various musculoskeletal disorders during the COVID-19 pandemic. Methods: This is a retrospective analysis of patients who underwent musculoskeletal telerehabilitation at a well-established physiotherapy centre in Central India between 1st April – 30th June 2020. A team of two experienced physiotherapists conducted one-on-one video-based physiotherapy sessions for every patient. The main outcome measures included pain reduction using the Numeric Pain Rating Scale (NPRS), functional goals achieved, and patient satisfaction. The effectiveness of treatment was determined based on the change in NPRS scores using the Wilcoxon signed-rank test. The relationship of percent change in NPRS and the functional score as well as the patient feedback score was obtained using Pearson’s correlation coefficient. Results: Of 77 patients who received telerehabilitation during the study period, 31 patients undergoing musculoskeletal rehabilitation who satisfied the eligibility criteria were included. There was a significant reduction in NPRS scores after rehabilitation (P < 0.0001). However, the median number of sessions and the baseline NPRS scores differed insignificantly for various patient characteristics. The distribution of functional score and change in NPRS demonstrated a moderately positive and significant correlation (P = 0.001). The relationship of patient feedback score with the change in NPRS was low positive. Conclusion: Telerehabilitation resulted in significant pain reduction among patients with various musculoskeletal disorders during the COVID-19 pandemic. A positive correlation was demonstrated between change in NPRS scores, patient-reported functional goals, and patient satisfaction. Hence, telerehabilitation provided by a trained physiotherapist can be an effective approach for conservative management of musculoskeletal pain. KEY WORDS: Telerehabilitation, Musculoskeletal disorder, Back pain, COVID-19.
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Meerhoff, Guus A., Arie C. Verburg, Renske M. Schapendonk, Juliette Cruijsberg, Maria W. G. Nijhuis-van der Sanden, Simone A. van Dulmen, and Philip J. Van der Wees. "Reliability, validity and discriminability of patient reported outcomes for non-specific low back pain in a nationwide physical therapy registry: A retrospective observational cohort study." PLOS ONE 16, no. 6 (June 3, 2021): e0251892. http://dx.doi.org/10.1371/journal.pone.0251892.
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Background A national clinical registry was established in the Netherlands containing data directly sampled from electronic health record systems of physical therapists (PTs). This registry aims to evaluate the potential of patient reported outcome measures (PROMs) to develop quality indicators (QIs) in physical therapy care. Purpose To test to what extent the collected PROM data are reliable, valid and discriminatory between practices in measuring outcomes of patients with non-specific low back pain (NSLBP). Methods In this retrospective cohort study 865 PT practices with 6,560 PTs voluntarily collected PROM data of patients with NSLBP, using the Quebec Back Pain Disability Scale (QBPDS), the Numeric Pain Rating Scale (NPRS) and the Patient Specific Functioning Scale (PSFS). Reliability was determined by analysing the completeness of the dataset, the comparability by using national reference data, and through checking selection bias in the included patients. Validity was tested using the known-groups contrast between patients with (sub)acute vs. chronic NSLBP. To determine discriminative ability of outcomes between PT practices, case-mix corrected hierarchical multilevel analyses were performed. Results Reliability was sufficient by confirming fifteen of the sixteen hypotheses: 59% of all patients opted in for data analysis, 42% of these included patients showed repeated measurement, comparing with reference data and potential selection bias showed < 5% between group differences, while differences between (sub)acute and chronic NSLB-groups were significantly larger than 5% (less treatment sessions, lager differences in outcomes in (sub)acute NSLB patients). In addition, all nine adjusted hierarchical multilevel models confirm that the collected dataset on outcomes in PT care is able to discriminate between practices using PROM results of patients with NSLBP (ICC-scores range 0.11–0.21). Limitations Although we have shown the reliability, validity and discriminative ability of the dataset in the quest to develop QIs, we are aware that reducing missing values in patient records and the selective participation of PTs that belong to the innovators needs attention in the next stages of implementation to avoid bias in the results. Conclusion PROMs of patients with NSLBP collected in the national clinical registry of KNGF are reliable, valid and able to discriminate between primary care PT practices.
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Ibsen, C., B. Schiøttz-Christensen, H. Melchiorsen, C. Nielsen, and T. Maribo. "Do Patient-Reported Outcome Measures describe functioning in patients with low back pain, using the Brief International Classification of Functioning, Disability and Health Core Set as a reference?" Journal of Rehabilitation Medicine 48, no. 7 (2016): 618–24. http://dx.doi.org/10.2340/16501977-2100.
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Hauser, Ross A., Johanna B. Lackner, Danielle Steilen-Matias, and David K. Harris. "A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain." Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders 9 (January 2016): CMAMD.S39160. http://dx.doi.org/10.4137/cmamd.s39160.
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Objective The aim of this study was to systematically review dextrose (D-glucose) prolotherapy efficacy in the treatment of chronic musculoskeletal pain. Data Sources Electronic databases PubMed, Healthline, OmniMedicalSearch, Medscape, and EMBASE were searched from 1990 to January 2016. Study Selection Prospectively designed studies that used dextrose as the sole active prolotherapy constituent were selected. Data Extraction Two independent reviewers rated studies for quality of evidence using the Physiotherapy Evidence Database assessment scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs, for level of evidence using a modified Sackett scale, and for clinically relevant pain score difference using minimal clinically important change criteria. Study population, methods, and results data were extracted and tabulated. Data Synthesis Fourteen RCTs, 1 case–control study, and 18 case series studies met the inclusion criteria and were evaluated. Pain conditions were clustered into tendinopathies, osteoarthritis (OA), spinal/pelvic, and myofascial pain. The RCTs were high-quality Level 1 evidence (Physiotherapy Evidence Database ≥8) and found dextrose injection superior to controls in Osgood–Schlatter disease, lateral epicondylitis of the elbow, traumatic rotator cuff injury, knee OA, finger OA, and myofascial pain; in biomechanical but not subjective measures in temporal mandibular joint; and comparable in a short-term RCT but superior in a long-term RCT in low back pain. Many observational studies were of high quality and reported consistent positive evidence in multiple studies of tendinopathies, knee OA, sacroiliac pain, and iliac crest pain that received RCT confirmation in separate studies. Eighteen studies combined patient self-rating (subjective) with psychometric, imaging, and/or biomechanical (objective) outcome measurement and found both positive subjective and objective outcomes in 16 studies and positive objective but not subjective outcomes in two studies. All 15 studies solely using subjective or psychometric measures reported positive findings. Conclusion Use of dextrose prolotherapy is supported for treatment of tendinopathies, knee and finger joint OA, and spinal/pelvic pain due to ligament dysfunction. Efficacy in acute pain, as first-line therapy, and in myofascial pain cannot be determined from the literature.
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Djurasovic, Mladen, Steven Glassman, Jeffrey L. Gum, Charles H. Crawford, R. Kirk Owens, and Leah Y. Carreon. "Health-related quality-of-life improvement with lumbar fusion in patients with lower-extremity arthritis." Journal of Neurosurgery: Spine 34, no. 1 (January 2021): 60–65. http://dx.doi.org/10.3171/2020.6.spine20759.
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OBJECTIVELumbar fusion can lead to significant improvements in patient-reported outcomes (PROs) in patients with degenerative conditions. It is unknown whether the presence of hip or knee arthritis confounds the responses of patients to low-back–specific PROs. This study examined PROs with lumbar fusion in patients with concomitant lower-extremity arthritis. The purpose of the current study was to examine whether patients with significant lower-extremity arthritis who undergo lumbar fusion achieve similar improvements in low-back–specific PROs compared to patients without lower-extremity arthritis.METHODSPatients were identified from a prospectively enrolled multicenter registry of patients undergoing lumbar fusion surgery for degenerative conditions. Two hundred thirty patients identified with lumbar fusion and who also had concomitant lower-extremity arthritis were propensity matched to 233 patients who did not have lower-extremity arthritis based on age, BMI, sex, smoking status, American Society of Anesthesiologists grade, number of levels fused, and surgical approach. One-year improvement in PROs, numeric rating scales (0–10) for back and leg pain, and the Oswestry Disability Index and EuroQol-5D scores were compared for patients with and without lower-extremity arthritis.RESULTSBaseline demographics and preoperative outcome measures did not differ between the two propensity-matched groups with 110 cases each. Patients with concomitant lower-extremity arthritis achieved similar improvement in health-related quality-of-life measures to patients without lower-extremity arthritis, with no significant differences between the groups (p > 0.10).CONCLUSIONSThe presence of lower-extremity arthritis does not adversely affect the results of lumbar fusion in properly selected patients. Patients with lower-extremity arthritis who undergo lumbar fusion can achieve meaningful improvement in PROs similar to patients without arthritis.
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Fawkes, Carol, and Dawn Carnes. "Patient reported outcomes in a large cohort of patients receiving osteopathic care in the United Kingdom." PLOS ONE 16, no. 4 (April 16, 2021): e0249719. http://dx.doi.org/10.1371/journal.pone.0249719.
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Objective The use of Patient Reported Outcome Measures (PROMs) to evaluate care is being advocated increasingly in clinical settings. Electronic data capture is both resource and environmentally friendly and convenient. This purpose of this study was to test and implement a nationwide system to collect routine PROM data from osteopathic patients using a web and mobile app. Methods A prospective study design was used to monitor outcomes of care for patients attending osteopathic clinics. Demographic and service data were collected, the primary outcomes were the Bournemouth Questionnaire and a Global Rating of Change score. Data concerning patients’ satisfaction and experience of care were collected also. Data were collected at baseline, one week, and six weeks post-treatment. Results A total of 1721 patients completed the PROM app questionnaire. The majority (65.8%) of patients who used the PROM app were between 40 and 69 years old with 11% being 70 years and over. At baseline 39.8% of patients reported they’d had their symptoms for 13 weeks or more. Low back pain was the most common symptom (55.8%). Patients reported high scores for both satisfaction and experience of osteopathic care: 88.1% were very satisfied at six weeks post-baseline and 93.5% reported very good experience at six weeks post-baseline. Data from the Global Rating of Change scale indicated that at one week post-baseline 89.1% of patients reported some measure of improvement, and at six weeks this figure rose to 92.8%. The mean sum score for the Bournemouth Questionnaire went from 30.8 at baseline to 13.3 at six weeks post-baseline. This represented a significant and clinically meaningful positive change score of 56.8%. Conclusion The app was well-completed and the data very encouraging. These data will help to form the basis for standards of care for patients attending osteopathic practices.
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Cooper, Jesse C., Jordan A. Gliedt, and Katherine A. Pohlman. "A descriptive analysis of clinical application of patient-reported outcome measures and screening tools for low back pain patients in US chiropractic teaching institutions." Journal of Chiropractic Education, July 28, 2020. http://dx.doi.org/10.7899/jce-19-12.
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Objective To describe the clinical use of patient-reported outcome measures (PROMs) and screening tools (STs) for low back pain (LBP) in clinics of chiropractic teaching institutions in the United States. Methods A descriptive analysis was completed with data collection achieved between June 2018 and March 2019. PROMs/STs were classified as disability/functional measures, pain measures, psychosocial measures, and other measures. Frequencies of use of PROM/ST instruments were calculated. Results Representatives from 18 of 19 chiropractic institutions (94.75%) provided a description of PROM/ST use for LBP in their teaching clinics. Seventeen institutions (94.4%) reported the routine clinical use of PROMs/STs for LBP. Disability/functional measures were the most common type of instruments used, followed by pain measures, psychosocial measures, and others. The 4 most common individual PROMs/STs reported were (1) Oswestry Disability Index, (2) a variation of a pain rating scale, (3) Keele STarT Back Tool, and (4) Patient Specific Functional Scale. Six out of 18 (33%) institutions reported the use of a PROM/ST specifically designed to focus on psychosocial influences. Conclusion Most chiropractic institution teaching clinics in the United States reported the clinical use of PROMs/STs for patients presenting with LBP. This mirrors trends in chiropractic literature of increasing use of PROMs/STs. A minority of institutions described the clinical use of a PROM/ST specifically designed to detect psychosocial influences.