Project description:This pilot randomized clinical trial assessed the feasibility of implementing motor control exercise (MCE) and patient education (PE) program for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community. Thirty patients with CLBP were recruited and randomly assigned to MCE, PE, or MCE plus PE groups. The MCE program was provided twice a week while the PE program was provided once a week all for 6 weeks. Feasibility was assessed through recruitment rate, treatment compliance, retention/dropout rate, report of adverse events, perceived helpfulness, overall satisfaction, and clinical outcome of pain (numeric pain rating scale) and functional disability (Oswestry Disability Index). Many patients were willing to participate in the study and the recruitment rate was 77%. Treatment compliance in all the three groups were >65% for supervised treatment sessions and <50% for prescribed home program. Retention rate was high and greater overall satisfaction with the interventions was reported. Compared with the baseline, all the three groups improved significantly in pain and disability (P<0.05) after 6 weeks. Pairwise comparison revealed that the MCE plus PE group was superior to the PE group for pain and to the MCE for disability (P<0.05), with large effect size. It was concluded that the designed interventions are promising and conducting a full-scale randomized clinical trial in the future is feasible to confirm the effectiveness of the interventions for the management CLBP in rural Nigeria. (Trial registration: ClinicalTrials.gov, NCT03398174).
Project description:Authors of meta-analyses concluded that exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low back pain (CLBP), particularly in health-care populations. Similar to health-care settings, community organizations provide wellness and lifestyle modification programs. Different versions of the Young Men's Christian Association (YMCA) Y's Way to a Healthy Back program were offered from 1974 to 2004. Champions of the YMCA program and authors of the pilot study designed a Healthy Back Curriculum to update and reintroduce the program. Objective: The research aim of this randomized pilot trial was to investigate the feasibility of a follow-up larger randomized controlled trial on the program's effectiveness for CLBP. The randomized pilot trial addressed subject recruitment, retention, and subject compliance with protocol. Methods: The pilot trial employed a 2-arm parallel group randomized design. Seventy-eight subjects aged 18 to 64 years with low back pain on at least half the days over the previous 6 months were assigned to either (1) a group stretching exercise arm with 12 weekly classes or (2) a self-care book arm. Results: Sixty participants, 30 in each group, completed the study. Out of the 130 members who accepted invitation, 60% were eligible. Retention rate over the 24-week study in the group stretching exercise arm was 30 out of 43 participants (70%). Participants in the group stretching exercise program attended an average of 5 of the 12 classes (42%). Participants completed baseline and follow-up self-report items with no missing data. Conclusion: The pilot study did not prove to be feasible based on the prespecified benchmarks. We suggest that a larger trial should include changes gleaned from the pilot study.
Project description:Background/objectiveExercise-based rehabilitation is a conservative management approach for individuals with low back pain. However, adherence rates for conservative management are often low and the reasons for this are not well described. The objective of this study was to evaluate predictors of adherence and patient-reported reasons for non-adherence after ceasing a supervised exercise-based rehabilitation program in individuals with low back pain.DesignRetrospective observational study.MethodsData was retrospectively analyzed from 5 rehabilitation clinics utilizing a standardized exercise-based rehabilitation program. Baseline demographics, diagnosis and symptom specific features, visit number, and discontinuation profiles were quantified for 2,243 patients who underwent the program.ResultsForty-three percent (43%) of participants were adherent to the program, with the majority (31.7%) discontinuing treatment prior to completion due to logistic and accessibility issues. Another 13.2% discontinued prior to the prescribed duration due to clinically significant improvements in pain and/or disability without formal discharge evaluation, whereas 8.3% did not continue due to lack of improvement. Finally, 6.0% were discharged for related and unrelated medical reasons including surgery. Individuals diagnosed with disc pathology were most likely to be adherent to the program.LimitationsThis study was a retrospective chart review with missing data for some variables. Future studies with a prospective design would increase quality of evidence.ConclusionsThe majority of individuals prescribed an in-clinic exercise-based rehabilitation program are non-adherent. Patient diagnosis was the most important predictor of adherence. For those who were not adherent, important barriers include personal issues, insufficient insurance authorization and lack of geographic accessibility.
Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.
Project description:BackgroundIt is widely believed that non-specific low back pain (LBP) consists of a number of subgroups which should be identified in order to improve treatment effects. In order to identify subgroups, patient characteristics that relate to different outcomes are searched for. However, LBP is often fluctuating or recurring rather than clearly limited in time. Therefore it would be relevant to consider outcome after completed treatment from a longitudinal perspective (describing "course patterns") instead of defining it from an arbitrarily selected end-point.AimsThe objectives of this pilot study were to investigate the interobserver reliability of a diagnostic classification system and to evaluate whether diagnostic classes or other baseline characteristics are associated with the LBP course pattern over a period of 18 weeks.MethodsPatients visiting one of 7 chiropractors because of LBP were classified according to a diagnostic classification system, which includes end-range loading, SI-joint pain provocation tests, neurological examination and tests for muscle tenderness and abnormal nerve tension. In addition, age, gender, duration of pain and presence of leg pain were registered in the patient's file. By weekly SMS-messages on their mobile phones, patients were asked how many days they had LBP the preceding week, and these answers were transformed into pain course patterns and the total number of LBP days.ResultsA total of 110 patients were included and 76 (69%) completed follow-up. Thirty-five patients were examined by two chiropractors. The agreement regarding diagnostic classes was 83% (95% CI: 70 - 96). The diagnostic classes were associated with the pain course patterns and number of LBP days. Patients with disc pain had the highest number of LBP days and patients with muscular pain reported the fewest (35 vs. 12 days, p < 0.01). Men had better outcome than women (17 vs. 29 days, p < 0.01) and patients without leg pain tended to have fewer LBP days than those with leg pain (21 vs.31 days, p = 0.06). Duration of LBP at the first visit was not associated with outcome.ConclusionsThe study indicated that there is a clinically meaningful relationship between diagnostic classes and the course of LBP. This should be evaluated in more depth.
Project description:BackgroundLow back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP.ObjectiveThe trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP.MethodsThis is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months.ResultsThe trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.ConclusionsThis RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.Trial registrationClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288.International registered report identifier (irrid)DERR1-10.2196/14720.
Project description:PurposeThe objective of this study was to evaluate the effects of an exercise program focusing on muscle stretching and endurance training on the 12-month incidence of low back pain (LBP) in office workers.MethodsA 12-month prospective cluster-randomized controlled trial was conducted in healthy office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance. Healthy office workers (n = 563) were randomly assigned at the cluster level into either intervention (n = 282) or control (n = 281) groups. Participants in the intervention group received an exercise program that included daily stretching exercise and twice-a-week muscle endurance training. Those in the control group received no intervention. The 12-month incidence of LBP was the primary outcome. Secondary outcome were pain intensity, disability level, and quality of life and health status. Analyses were performed using the Cox proportional hazard models.ResultsOver the 12-month follow-up, 8.8% of participants in the intervention group and 19.7% in the control group developed incidence of LBP. Hazard rate ratios showed a protective effect of the exercise program for LBP (HR = 0.37, 95% CI 0.22-0.64) after adjusting for biopsychosocial factors. There was no significant difference in pain intensity, disability, and quality of life and health status between those who reported incidence of LBP in the intervention and control groups.ConclusionAn exercise program consisting of muscle stretching and endurance training is an effective intervention to reduce incident LBP for office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance.
Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.