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Patient education materials for non-specific low back pain and sciatica: a protocol for a systematic review and meta-analysis.

ABSTRACT: INTRODUCTION:Low back pain accounts for more disability than any other musculoskeletal condition and is associated with severe economic burden. Patients commonly present with negative beliefs about low back pain and this can have detrimental effects on their health outcomes. Providing evidence-based, patient-centred education that meets patient needs could help address these negative beliefs and alleviate the substantial low back pain burden. The primary aim of this review is to investigate the effectiveness of patient education materials on immediate process, clinical and health system outcomes. METHODS AND ANALYSIS:The search strategy was developed in collaboration with a librarian and systematic searches will be performed in MEDLINE, EMBASE, CINAHL, PsycINFO and SPORTDiscus. We will also search trial registries and grey literature through the OpenGrey database. Study selection will include a title and abstract scan and full-text review by two authors. Only randomised controlled trials will be included in this review. Trials must include patients with low back pain or sciatica and investigate educational interventions with at least one of the following contrasts: (1) education alone versus no intervention; (2) education alone versus another intervention; (3) education in addition to another intervention versus the same intervention with no education. Data extraction, risk of bias and grading of the quality of evidence will be performed independently by two reviewers. Risk of bias will be assessed using the PEDro scale, and the quality of evidence will be assessed with the Grades of Recommendation, Assessment, Development and Evaluation approach. A random-effects model will be used for each contrast, and results will be pooled if the participants, interventions, and outcomes are homogeneous. If heterogeneity is high (I2 >75%), we will evaluate the magnitude and direction of the differences in effect sizes across studies to determine if it remains reasonable to pool the results. Analyses of acute and subacute low back pain (less than 12 weeks duration) will be performed separately from chronic low back pain (12 weeks or greater duration). Likewise, analyses of short-term (less than 6 months) and long-term (6 months or greater) follow-up will be performed separately. Subgroup analyses will be performed on non-specific low back pain, sciatica and mixed populations. ETHICS AND DISSEMINATION:Ethical approval is not required for this review. This study, along with its results, will be published in a peer-reviewed journal.

SUBMITTER: Furlong B

PROVIDER: S-EPMC7470487 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Patient education materials for non-specific low back pain and sciatica: a protocol for a systematic review and meta-analysis.

Furlong Bradley B Aubrey-Bassler Kris K Etchegary Holly H Pike Andrea A Darmonkow Georgia G Swab Michelle M Hall Amanda A

BMJ open 20200902 9

<h4>Introduction</h4>Low back pain accounts for more disability than any other musculoskeletal condition and is associated with severe economic burden. Patients commonly present with negative beliefs about low back pain and this can have detrimental effects on their health outcomes. Providing evidence-based, patient-centred education that meets patient needs could help address these negative beliefs and alleviate the substantial low back pain burden. The primary aim of this review is to investig ...[more]

PMID: 32878763

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Project description:Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery.The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome.This study was a secondary analysis of the COPE randomized controlled trial.Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline - posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis.Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 [95% CI = 0.03 to 0.16]; pain catastrophizing standardized indirect effect = 0.05 [95% CI = 0.01 to 0.12]). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant.This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects.The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.

Project description:ImportanceMany patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.ObjectiveTo determine the effectiveness of intensive patient education for patients with acute low back pain.Design, setting, and participantsThis randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks' duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education.InterventionsAll participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).Main outcomes and measuresThe primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.ResultsOf 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, -0.3 [95% CI, -1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, -1.6 points on a 24-point scale [95% CI, -3.1 to -0.1]) and 3 months (mean difference, -1.7 points, [95% CI, -3.2 to -0.2]) but not at 6 or 12 months.Conclusions and relevanceAdding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.Trial registrationAustralian Clinical Trial Registration Number: 12612001180808.

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.

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Patient education materials for non-specific low back pain and sciatica: a protocol for a systematic review and meta-analysis.

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Patient education materials for non-specific low back pain and sciatica: a protocol for a systematic review and meta-analysis.

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