Exercises for the prevention of non-specific low back pain.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the effects of exercise alone or exercise plus education compared with inactive control or education alone to prevent non-specific LBP.

DiTA: helping you search for evidence of diagnostic test accuracy in physical therapy.

BACKGROUND: Physical therapists use diagnostic tests in a variety of settings. Choosing the best diagnostic test to apply in a particular situation can be difficult. The choice of diagnostic test should be informed, at least in part, by evidence of test accuracy. Finding evidence of diagnostic test accuracy has, until recently, been challenging. Ideally, there would exist a database that comprehensively indexes evidence on diagnostic tests relevant to physical therapy practice, is free to access, and is easy to use. OBJECTIVE: This Masterclass will describe the DiTA (Diagnostic Test Accuracy) database (dita.org.au) including its development and search interface, and provide advice on how to search and retrieve records. DISCUSSION: DiTA indexes more than 2400 primary studies and systematic reviews of diagnostic test accuracy relevant to physical therapy practice. Users can search DiTA using text fields and dropdown lists to find evidence of diagnostic test accuracy. The database is freely accessible on the internet. Since its launch, DiTA has been accessed from almost every country in the world, the largest number of searches having been conducted from Brazil.

Single-group studies in leading physical therapy journals commonly make inappropriate conclusions regarding treatment effect modifiers. A systematic review.

BACKGROUND: Characteristics that identify patients who respond differently to certain interventions are called treatment effect modifiers. Some studies inappropriately report the presence of treatment effect modifiers without adequate study designs. OBJECTIVES: To evaluate what proportion of single-group studies published in leading physical therapy journals inappropriately report treatment effect modifiers, and to assess whether the proportion varies over time or between journals. METHODS: A systematic review was conducted of studies published in eight leading physical therapy journals since 2000. Eligible studies were single-group studies (e.g., cohort study or secondary analysis of treatment arm of randomised controlled trial) that investigated any condition, treatment or outcome. Studies that suggested participants with certain baseline characteristics responded better/or worse to the treatment, were considered to have reported inappropriately. Studies reporting that participants with certain baseline characteristics had improved outcomes but did not state it was due to the treatment were considered to have reported appropriately. The proportion of inappropriate reporting was compared over time and between journals. RESULTS: Of the 145 included studies, 73 (50.3%) were categorised as inappropriately reporting treatment effect modifiers. The proportion of inappropriate reporting was highest in the most recent period, 2018 - 2022 (59.6%) and 2006 - 2011 (55.6%). The proportion of inappropriate reporting varied substantially between journals from 0% (Journal of Physiotherapy) to 91.7% (Journal of Neurologic Physical Therapy). CONCLUSIONS: A large proportion (50.3%) of single-arm studies in leading physical therapy journals inappropriately report treatment effect modifiers. This inappropriate reporting risks misleading clinicians when selecting interventions for individual patients.

Epidural Corticosteroid Injections for Sciatica: An Abridged Cochrane Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic with meta-analysis OBJECTIVES.: The aim of this study was to investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection in reducing leg pain and disability in patients with sciatica. SUMMARY OF BACKGROUND DATA: Conservative treatments, including pharmacological and nonpharmacological treatments, are typically the first treatment options for sciatica but the evidence to support their use is limited. The overall quality of evidence found by previous systematic reviews varies between moderate and high, which suggests that future trials may change the conclusions. New placebo-controlled randomized trials have been published recently which highlights the importance of an updated systematic review. METHODS: The searches were performed without language restrictions in the following databases from 2012 to 25 September 2019: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PubMed, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and trial registers. We included placebo-controlled randomized trials investigating epidural corticosteroid injections in patients with sciatica. The primary outcomes were leg pain intensity and disability. The secondary outcomes were adverse events, overall pain, and back pain intensity. We grouped similar trials according to outcome measures and their respective follow-up time points. Short-term follow-up (>2 weeks but ≤3 months) was considered the primary follow-up time point due to the expected mechanism of action of epidural corticosteroid injection. Weighted mean differences (MDs) and risk ratios (RRs) with their respective 95% confidence intervals (CIs) were estimated. We assessed the overall quality of evidence using the GRADE approach and conducted the analyses using random effects. RESULTS: We included 25 clinical trials (from 29 publications) providing data for a total of 2470 participants with sciatica, an increase of six trials when compared to the previous review. Epidural corticosteroid injections were probably more effective than placebo in reducing short-term leg pain (MD -4.93, 95% CI -8.77 to -1.09 on a 0-100 scale), short-term disability (MD -4.18, 95% CI: -6.04 to -2.17 on a 0-100 scale) and may be slightly more effective in reducing short-term overall pain (MD -9.35, 95% CI -14.05 to -4.65 on a 0-100 scale). There were mostly minor adverse events (i.e., without hospitalization) after epidural corticosteroid injections and placebo injections without difference between groups (RR 1.14, 95% CI: 0.91-1.42). The quality of evidence was at best moderate mostly due to problems with trial design and inconsistency. CONCLUSION: A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term. There is uncertainty on safety due to very low-quality evidence. LEVEL OF EVIDENCE: 1.

TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.

BACKGROUND: This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). OBJECTIVES: TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. METHODS: TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. DISCUSSION: This paper will provide a detailed description of the planned analyses for the TOPS trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).

Measurement properties of quality assessment tools for studies of diagnostic accuracy.

OBJECTIVES: To determine the reliability, internal consistency, measurement error, convergent validity, and floor and ceiling effects of three quality assessment tools commonly used to evaluate the quality of diagnostic test accuracy studies in physical therapy. A secondary aim was to describe the quality of a sample of diagnostic accuracy studies. STUDY DESIGN AND SETTING: 50 studies were randomly selected from a comprehensive database of physical therapy-relevant diagnostic accuracy studies. Two reviewers independently rated each study with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS), Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) and Diagnostic Accuracy Quality Scale (DAQS) tools in random sequence. RESULTS: Only 7% of QUADAS items, 14% of QUADAS-2 items, and 33% of DAQS items had at least moderate inter-rater reliability (kappa>0.40). Internal consistency and convergent validity measures were acceptable (>0.70) in 33% and 50% of cases respectively. Floor or ceiling effects were not present in any tool. The quality of studies was mixed: most avoided case-control sampling strategies and used the same reference standard on all subjects, but many failed to enroll a consecutive or random sample of subjects or provide confidence intervals about estimates of diagnostic accuracy. CONCLUSION: The QUADAS, QUADAS-2 and DAQS tools provide unreliable estimates of the quality of studies of diagnostic accuracy in physical therapy.

McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up.

BACKGROUND: The McKenzie Method of Mechanical Diagnosis and Therapy (MDT) is one of the exercise approaches recommended by low back pain (LBP) guidelines. We investigated the efficacy of MDT compared with placebo in patients with chronic LBP. METHODS: This was a prospectively registered, two-arm randomised placebo controlled trial, with a blinded assessor. A total of 148 patients seeking care for chronic LBP were randomly allocated to either MDT (n=74) or placebo (n=74). Patients from both groups received 10 treatment sessions over 5 weeks. Patients from both groups also received an educational booklet. Clinical outcomes were obtained at the end of treatment (5 weeks) and 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity and disability at the end of treatment (5 weeks). We also conducted a subgroup analysis to identify potential treatment effect modifiers that could predict a better response to MDT treatment. RESULTS: The MDT group had greater improvements in pain intensity at the end of treatment (mean difference (MD) -1.00, 95% CI -2.09 to -0.01) but not for disability (MD -0.84, 95% CI -2.62 to 0.93). We did not detect between-group differences for any secondary outcomes, nor were any treatment effect modifiers identified. Patients did not report any adverse events. CONCLUSION: We found a small and likely not clinically relevant difference in pain intensity favouring the MDT method immediately at the end of 5 weeks of treatment but not for disability. No other difference was found for any of the primary or secondary outcomes at any follow-up times. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02123394).

Pilates for low back pain.

BACKGROUND: Non-specific low back pain is a major health problem worldwide. Interventions based on exercises have been the most commonly used treatments for patients with this condition. Over the past few years, the Pilates method has been one of the most popular exercise programmes used in clinical practice. OBJECTIVES: To determine the effects of the Pilates method for patients with non-specific acute, subacute or chronic low back pain. SEARCH METHODS: We conducted the searches in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDro and SPORTDiscus from the date of their inception to March 2014. We updated the search in June 2015 but these results have not yet been incorporated. We also searched the reference lists of eligible papers as well as six trial registry websites. We placed no limitations on language or date of publication. SELECTION CRITERIA: We only included randomized controlled trials that examined the effectiveness of Pilates intervention in adults with acute, subacute or chronic non-specific low back pain. The primary outcomes considered were pain, disability, global impression of recovery and quality of life. DATA COLLECTION AND ANALYSIS: Two independent raters performed the assessment of risk of bias in the included studies using the 'Risk of bias' assessment tool recommended by The Cochrane Collaboration. We also assessed clinical relevance by scoring five questions related to this domain as 'yes', 'no' or 'unclear'. We evaluated the overall quality of evidence using the GRADE approach and for effect sizes we used three levels: small (mean difference (MD) < 10% of the scale), medium (MD 10% to 20% of the scale) or large (MD > 20% of the scale). We converted outcome measures to a common 0 to 100 scale when different scales were used. MAIN RESULTS: The search retrieved 126 trials; 10 fulfilled the inclusion criteria and we included them in the review (a total sample of 510 participants). Seven studies were considered to have low risk of bias, and three were considered as high risk of bias.A total of six trials compared Pilates to minimal intervention. There is low quality evidence that Pilates reduces pain compared with minimal intervention, with a medium effect size at short-term follow-up (less than three months after randomization) (MD -14.05, 95% confidence interval (CI) -18.91 to -9.19). For intermediate-term follow-up (at least three months but less than 12 months after randomization), two trials provided moderate quality evidence that Pilates reduces pain compared to minimal intervention, with a medium effect size (MD -10.54, 95% CI -18.46 to -2.62). Based on five trials, there is low quality evidence that Pilates improves disability compared with minimal intervention, with a small effect size at short-term follow-up (MD -7.95, 95% CI -13.23 to -2.67), and moderate quality evidence for an intermediate-term effect with a medium effect size (MD -11.17, 95% CI -18.41 to -3.92). Based on one trial and low quality evidence, a significant short-term effect with a small effect size was reported for function (MD 1.10, 95% CI 0.23 to 1.97) and global impression of recovery (MD 1.50, 95% CI 0.70 to 2.30), but not at intermediate-term follow-up for either outcome.Four trials compared Pilates to other exercises. For the outcome pain, we presented the results as a narrative synthesis due to the high level of heterogeneity. At short-term follow-up, based on low quality evidence, two trials demonstrated a significant effect in favour of Pilates and one trial did not find a significant difference. At intermediate-term follow-up, based on low quality evidence, one trial reported a significant effect in favour of Pilates, and one trial reported a non-significant difference for this comparison. For disability, there is moderate quality evidence that there is no significant difference between Pilates and other exercise either in the short term (MD -3.29, 95% CI -6.82 to 0.24) or in the intermediate term (MD -0.91, 95% CI -5.02 to 3.20) based on two studies for each comparison. Based on low quality evidence and one trial, there was no significant difference in function between Pilates and other exercises at short-term follow-up (MD 0.10, 95% CI -2.44 to 2.64), but there was a significant effect in favour of other exercises for intermediate-term function, with a small effect size (MD -3.60, 95% CI -7.00 to -0.20). Global impression of recovery was not assessed in this comparison and none of the trials included quality of life outcomes. Two trials assessed adverse events in this review, one did not find any adverse events, and another reported minor events. AUTHORS CONCLUSIONS: We did not find any high quality evidence for any of the treatment comparisons, outcomes or follow-up periods investigated. However, there is low to moderate quality evidence that Pilates is more effective than minimal intervention for pain and disability. When Pilates was compared with other exercises we found a small effect for function at intermediate-term follow-up. Thus, while there is some evidence for the effectiveness of Pilates for low back pain, there is no conclusive evidence that it is superior to other forms of exercises. The decision to use Pilates for low back pain may be based on the patient's or care provider's preferences, and costs.

Prevention of Low Back Pain: A Systematic Review and Meta-analysis.

IMPORTANCE: Existing guidelines and systematic reviews lack clear recommendations for prevention of low back pain (LBP). OBJECTIVE: To investigate the effectiveness of interventions for prevention of LBP. DATA SOURCES: MEDLINE, EMBASE, Physiotherapy Evidence Database Scale, and Cochrane Central Register of Controlled Trials from inception to November 22, 2014. STUDY SELECTION: Randomized clinical trials of prevention strategies for nonspecific LBP. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed the risk of bias. The Physiotherapy Evidence Database Scale was used to evaluate the risk-of-bias. The Grading of Recommendations Assessment, Development, and Evaluation system was used to describe the quality of evidence. MAIN OUTCOMES AND MEASURES: The primary outcome measure was an episode of LBP, and the secondary outcome measure was an episode of sick leave associated with LBP. We calculated relative risks (RRs) and 95% CIs using random-effects models. RESULTS: The literature search identified 6133 potentially eligible studies; of these, 23 published reports (on 21 different randomized clinical trials including 30,850 unique participants) met the inclusion criteria. With results presented as RRs (95% CIs), there was moderate-quality evidence that exercise combined with education reduces the risk of an episode of LBP (0.55 [0.41-0.74]) and low-quality evidence of no effect on sick leave (0.74 [0.44-1.26]). Low- to very low-quality evidence suggested that exercise alone may reduce the risk of both an LBP episode (0.65 [0.50-0.86]) and use of sick leave (0.22 [0.06-0.76]). For education alone, there was moderate- to very low-quality evidence of no effect on LBP (1.03 [0.83-1.27]) or sick leave (0.87 [0.47-1.60]). There was low- to very low-quality evidence that back belts do not reduce the risk of LBP episodes (1.01 [0.71-1.44]) or sick leave (0.87 [0.47-1.60]). There was low-quality evidence of no protective effect of shoe insoles on LBP (1.01 [0.74-1.40]). CONCLUSION AND RELEVANCE: The current evidence suggests that exercise alone or in combination with education is effective for preventing LBP. Other interventions, including education alone, back belts, and shoe insoles, do not appear to prevent LBP. Whether education, training, or ergonomic adjustments prevent sick leave is uncertain because the quality of evidence is low.

Efficacy of the McKenzie method in patients with chronic nonspecific low back pain: a protocol of randomized placebo-controlled trial.

BACKGROUND: The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain. OBJECTIVE: The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain. DESIGN: An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted. SETTING: This study will be conducted in physical therapy clinics in São Paulo, Brazil. PARTICIPANTS: The participants will be 148 patients seeking care for chronic nonspecific low back pain. INTERVENTION: Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks). MEASUREMENTS: The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor. LIMITATIONS: Therapists will not be blinded. CONCLUSIONS: This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.

The Brazilian-Portuguese versions of the McGill Pain Questionnaire were reproducible, valid, and responsive in patients with musculoskeletal pain.

OBJECTIVE: To cross-culturally adapt the Short Form of the McGill Pain Questionnaire (SF-MPQ) into Brazilian-Portuguese and test the clinimetric properties of the newly developed SF-MPQ and the previously cross-culturally adapted Brazilian-Portuguese Long Form of the McGill Pain Questionnaire (LF-MPQ). STUDY DESIGN AND SETTING: The SF-MPQ was translated and adapted into Brazilian-Portuguese following recommendations from current guidelines. Both SF-MPQ and LF-MPQ were administered in a prospective longitudinal design to 203 patients with a range of musculoskeletal conditions to evaluate their clinimetric properties. RESULTS: Both questionnaires demonstrated high levels of internal consistency (Cronbach α range=0.70-0.79), reliability (intraclass correlation coefficient(2,1) range=0.69-0.85), and agreement (standard error of the measurement range=0.80-6.92). We observed positive and moderate-to-high correlations among the SF-MPQ, the LF-MPQ, and the Numerical Rating Scale (Pearson r ranging from 0.49 to 0.68). No ceiling or floor effects were detected. Both versions demonstrated acceptable levels of responsiveness (effect size range=0.30-0.60; correlations range=0.23-0.51; and area under the curve range=0.56-0.76). CONCLUSIONS: The Brazilian-Portuguese versions of the MPQ were found to be reproducible, valid, and responsive for the assessment of pain in patients with musculoskeletal conditions.