Leonardo O. P. Costa

The prognosis of acute and persistent low-back pain: a meta-analysis

Background: Although low-back pain is a highly prevalent condition, its clinical course remains uncertain. Our main objective was to systematically review the literature on the clinical course of pain and disability in patients with acute and persistent low-back pain. Our secondary objective was to investigate whether pain and disability have similar courses. Methods: We performed a meta-analysis of inception cohort studies. We identified eligible studies by searching MEDLINE, Embase and CINAHL. We included prospective studies that enrolled an episode-inception cohort of patients with acute or persistent low-back pain and that measured pain, disability or recovery. Two independent reviewers extracted data and assessed methodologic quality. We used mixed models to determine pooled estimates of pain and disability over time. Results: Data from 33 discrete cohorts (11 166 participants) were included in the review. The variance-weighted mean pain score (out of a maximum score of 100) was 52 (95% CI 48–57) at baseline, 23 (95% CI 21–25) at 6 weeks, 12 (95% CI 9–15) at 26 weeks and 6 (95% CI 3–10) at 52 weeks after the onset of pain for cohorts with acute pain. Among cohorts with persistent pain, the variance-weighted mean pain score (out of 100) was 51 (95% CI 44–59) at baseline, 33 (95% CI 29–38) at 6 weeks, 26 (95% CI 20–33) at 26 weeks and 23 (95% CI 16–30) at 52 weeks after the onset of pain. The course of disability outcomes was similar to the time course of pain outcomes in the acute pain cohorts, but the pain outcomes were slightly worse than disability outcomes in the persistent pain cohorts. Interpretation: Patients who presented with acute or persistent low-back pain improved markedly in the first six weeks. After that time improvement slowed. Low to moderate levels of pain and disability were still present at one year, especially in the cohorts with persistent pain.

Motor control exercise for chronic low back pain: A randomized placebo-controlled trial

Background The evidence that exercise intervention is effective for treatment of chronic low back pain comes from trials that are not placebo-controlled. Objective The purpose of this study was to investigate the efficacy of motor control exercise for people with chronic low back pain. Design This was a randomized, placebo-controlled trial. Setting The study was conducted in an outpatient physical therapy department in Australia. Patients The participants were 154 patients with chronic low back pain of more than 12 weeks’ duration. Intervention Twelve sessions of motor control exercise (ie, exercises designed to improve function of specific muscles of the low back region and the control of posture and movement) or placebo (ie, detuned ultrasound therapy and detuned short-wave therapy) were conducted over 8 weeks. Measurements Primary outcomes were pain intensity, activity (measured by the Patient-Specific Functional Scale), and patients global impression of recovery measured at 2 months. Secondary outcomes were pain; activity (measured by the Patient-Specific Functional Scale); patients global impression of recovery measured at 6 and 12 months; activity limitation (measured by the Roland-Morris Disability Questionnaire) at 2, 6, and 12 months; and risk of persistent or recurrent pain at 12 months. Results The exercise intervention improved activity and patients global impression of recovery but did not clearly reduce pain at 2 months. The mean effect of exercise on activity (measured by the Patient-Specific Functional Scale) was 1.1 points (95% confidence interval [CI]=0.3 to 1.8), the mean effect on global impression of recovery was 1.5 points (95% CI=0.4 to 2.5), and the mean effect on pain was 0.9 points (95% CI=−0.01 to 1.8), all measured on 11-point scales. Secondary outcomes also favored motor control exercise. Limitation Clinicians could not be blinded to the intervention they provided. Conclusions Motor control exercise produced short-term improvements in global impression of recovery and activity, but not pain, for people with chronic low back pain. Most of the effects observed in the short term were maintained at the 6- and 12-month follow-ups.

CENTRAL, PEDro, PubMed, and EMBASE Are the Most Comprehensive Databases Indexing Randomized Controlled Trials of Physical Therapy Interventions

Background Many bibliographic databases index research studies evaluating the effects of health care interventions. One study has concluded that the Physiotherapy Evidence Database (PEDro) has the most complete indexing of reports of randomized controlled trials of physical therapy interventions, but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro. Objective The purpose of this study was to compare the completeness of indexing of reports of randomized controlled trials of physical therapy interventions by 8 bibliographic databases. Design This study was an audit of bibliographic databases. Methods Prespecified criteria were used to identify 400 reports of randomized controlled trials from the reference lists of systematic reviews published in 2008 that evaluated physical therapy interventions. Eight databases (AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO, and PubMed) were searched for each trial report. The proportion of the 400 trial reports indexed by each database was calculated. Results The proportions of the 400 trial reports indexed by the databases were as follows: CENTRAL, 95%; PEDro, 92%; PubMed, 89%; EMBASE, 88%; CINAHL, 53%; AMED, 50%; Hooked on Evidence, 45%; and PsycINFO, 6%. Almost all of the trial reports (99%) were found in at least 1 database, and 88% were indexed by 4 or more databases. Four trial reports were uniquely indexed by a single database only (2 in CENTRAL and 1 each in PEDro and PubMed). Limitations The results are only applicable to searching for English-language published reports of randomized controlled trials evaluating physical therapy interventions. Conclusions The 4 most comprehensive databases of trial reports evaluating physical therapy interventions were CENTRAL, PEDro, PubMed, and EMBASE. Clinicians seeking quick answers to clinical questions could search any of these databases knowing that all are reasonably comprehensive. PEDro, unlike the other 3 most complete databases, is specific to physical therapy, so studies not relevant to physical therapy are less likely to be retrieved. Researchers could use CENTRAL, PEDro, PubMed, and EMBASE in combination to conduct exhaustive searches for randomized trials in physical therapy.

Rehabilitation After Lumbar Disc Surgery: An Update Cochrane Review

Study Design. Cochrane systematic review of randomized controlled trials. Objective. To evaluate the effects of active rehabilitation for adults after first-time lumbar disc surgery. Summary of Background Data. Several rehabilitation programs are available for individuals after lumbar disc surgery, however, little is known about the efficacy of these treatments. Methods. Search strategies were performed on CENTRAL (The Cochrane Library 2007, Issue 2) and MEDLINE, EMBASE, CINAHL, and PsycINFO up to May 2007. All randomized controlled trials without language limitations were included. Pairs of review authors independently assessed studies for eligibility and risk of bias. A meta-analysis was performed with clinically homogeneous studies. The GRADE approach was used to determine the quality of evidence. Results. Fourteen studies were included, 7 of which had a low risk of bias. Most programs were only assessed in 1 study. Statistical pooling was only completed for 3 comparisons in which exercises started 4 to 6 weeks postsurgery: exercise programs versus no treatment, high versus low intensity exercise programs, and supervised versus home exercises. We found low quality evidence (3randomized controlled trials [RCTs], N = 122) that exercises are more effective than no treatment for pain atshort-term follow-up (weighted mean difference [WMD]:−11.13; 95% CI: −18.44 to −3.82) and moderate evidence (2 RCTs, N = 102) that exercises are more effective for functional status on short-term follow-up (WMD: −6.50; 95% CI: −9.26 to −3.74). None of the studies reported that exercises increased the reoperation rate. We also found low quality evidence (2 RCTs, N = 103) that high intensity exercises are slightly more effective than low intensity exercise programs for pain in the short-term (WMD: −10.67; 95% CI: −17.04 to −4.30) and moderate evidence (2 RCTs, N = 103) that they are more effective for functional status in the short-term (standardized mean difference [SMD] −0.77; 95% CI: −1.17 to −0.36). Finally, we found low quality evidence (3 RCTs, N = 95) that there were no significant differences between supervised and home exercises for short-term pain relief (SMD: −1.12; 95% CI: −2.77-0.53) or functional status (3 RCT, N = 95; SMD −1.17; 95% CI: −2.63-0.28). Conclusion. Exercise programs starting 4 to 6 weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment. High intensity exercise programs seem to lead to a faster decrease in pain and disability than low intensity programs. There were no significant differences between supervised and home exercises for pain relief, disability, or global perceived effect. There is no evidence that active programs increase the reoperation rate after first-time lumbar surgery.

The relevance of cross-cultural adaptation and clinimetrics for physical therapy instruments

Background: Self-report outcome measures (questionnaires) are widely used by physiotherapists for measuring patient’s health status or treatment outcomes. Most of these measurement tools were developed in English and their usefulness is very limited in non-English speaking countries such as Brazil. The only way to solve this problem is to properly adapt the relevant questionnaires into a target language and culture (e.g. Brazilian-Portuguese) and then test the instrument by checking its psychometric (clinimetric) characteristics. Objectives: The purpose of this paper was to present relevant issues in the process of cross-cultural adaptations and clinimetric testing for self-report outcome measurements. Advice on how to perform a cross-cultural adaptation, how to properly check the clinimetric properties, how to select a relevant questionnaire and how to evaluate the quality of an adapted questionnaire are provided. Additionally we present all Brazilian-Portuguese cross-cultural adaptations of low back pain measurements that we know of. Conclusions: There is a clear need for more effort in the field of cross-cultural adaptation and clinimetrics, without proper instruments, the management of patients from non-English speaking countries is compromised.

The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606]

BackgroundWhile one in ten Australians suffer from chronic low back pain this condition remains extremely difficult to treat. Many contemporary treatments are of unknown value. One potentially useful therapy is the use of motor control exercise. This therapy has a biologically plausible effect, is readily available in primary care and it is of modest cost. However, to date, the efficacy of motor control exercise has not been established.MethodsThis paper describes the protocol for a clinical trial comparing the effects of motor control exercise versus placebo in the treatment of chronic non-specific low back pain. One hundred and fifty-four participants will be randomly allocated to receive an 8-week program of motor control exercise or placebo (detuned short wave and detuned ultrasound). Measures of outcomes will be obtained at follow-up appointments at 2, 6 and 12 months after randomisation. The primary outcomes are: pain, global perceived effect and patient-generated measure of disability at 2 months and recurrence at 12 months.DiscussionThis trial will be the first placebo-controlled trial of motor control exercise. The results will inform best practice for treating chronic low back pain and prevent its occurrence.

Clinical Trial Registration in Physical Therapy Journals: Recommendations from the International Society of Physiotherapy Journal Editors

Clinical trial registration involves placing the protocol for a clinical trial on a free, publicly available, and electronically searchable register. Registration is considered to be prospective if the protocol is registered before the trial commences (ie, before the first participant is enrolled). Prospective registration has several potential advantages. It could help avoid trials being duplicated unnecessarily, and it could allow people with health problems to identify trials in which they might participate. Perhaps more important, however, it tackles 2 big problems in clinical research: selective reporting and publication bias. Selective reporting involves investigators reporting only the most favorable results when they publish a trial, instead of reporting the results for all the outcomes that were measured. Reporting only favorable outcomes can create a misleading appearance of the effect of a therapy in the published literature. For example, imagine that a completely ineffective intervention is tested across several trials, and each trial measures multiple outcomes. Most outcomes will show no significant effect of the intervention. However, occasionally an outcome will show significant benefit or harm simply by chance. If the researchers publish the positive outcomes but not all of the nonsignificant and negative outcomes, readers could interpret falsely that the intervention is beneficial. A similar problem could occur when outcomes are analyzed at multiple time points. Researchers may report that an intervention improves walking speed at 6 months, but fail to mention that it does not improve walking speed at 1, 2, 3, 9, 12, and 24 months. Prospective registration of clinical trials combats this problem in several ways. Journal editors and reviewers can compare the range of outcomes reported in a manuscript against those listed in the registered protocol, requesting that any discrepancies be resolved by following the protocol. Readers also can compare the outcomes in the registered protocol against …

A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

BackgroundLow back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials.Methods/DesignAn International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients’ responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants’ responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged.DiscussionWe present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.

Analysis of reporting of systematic reviews in physical therapy published in Portuguese

BACKGROUND Systematic reviews are considered the best design to synthesize all existing information of a given research topic. To date, there is no study that investigated the quality of reporting of systematic reviews relevant to physical therapy published in Portuguese. OBJECTIVE To analyse the quality of reporting of systematic reviews in the field of physical therapy published in Portuguese by using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) checklist. METHOD All systematic reviews published in Portuguese that were indexed on PEDro database up to August 2011 were included. The quality of reporting of the eligible papers was analysed by using the PRISMA checklist. Each quality assessment was performed by two independent reviewers with arbitration of a third reviewer if necessary. RESULTS A total of 37 systematic reviews were identified. These studies were published between 2003 and 2010. Less than 30% of the PRISMA checklist items were satisfied, being most of the items related to the introduction and discussion sections. No improvements over time were observed. CONCLUSIONS Most of the studies did not satisfy the items from the PRISMA Checklist. It seems that most of authors did not know the existence of this checklist. The implementation of reporting statements such as the PRISMA statement by Portuguese-written journals is likely to help authors to write their systematic reviews in a more transparent and clear way.

Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review

Study Design. A systematic review. Objective. The aim of this review was to evaluate the effectiveness of motor control exercise (MCE) in patients with nonspecific low back pain (LBP). Summary of Background Data. MCE is a common form of exercise used for managing LBP. MCE focuses on the activation of the deep trunk muscles and targets the restoration of control and coordination of these muscles, progressing to more complex and functional tasks integrating the activation of deep and global trunk muscles. Methods. We conducted electronic searches of CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers from their inception up to April 2015. Two independent review authors screened the search results, assessed risk of bias, and extracted the data. A third reviewer resolved any disagreement. We included randomized controlled trials comparing MCE with no treatment, another treatment, or as a supplement to other interventions in patients with nonspecific LBP. Primary outcomes were pain intensity and disability. We assessed risk of bias using the Cochrane Back and Neck (CBN) Review Group 12-item criteria. We combined results in a meta-analysis expressed as mean difference and 95% confidence interval. We assessed the overall quality of the evidence using the GRADE approach. Results. We included 32 trials (n = 2628). Most included trials had a low risk of bias. For acute LBP, low to moderate quality evidence indicates no clinically important differences between MCE and spinal manipulative therapy or other forms of exercise. There is very low-quality evidence that the addition of MCE to medical management does not provide clinically important improvements. For recurrence at one year, there is very low-quality evidence that MCE and medical management decrease the risk of recurrence. For chronic LBP, there is low to moderate quality evidence that MCE is effective for reducing pain compared with minimal intervention. There is low to high-quality evidence that MCE is not clinically more effective than other exercises or manual therapy. There is very low to low quality evidence that MCE is clinically more effective than exercise and electrophysical agents (EPAs) or telerehabilitation for pain and disability. Conclusion. MCE is probably more effective than a minimal intervention for reducing pain, but probably does not have an important effect on disability, in patients with chronic LBP. There was no clinically important difference between MCE and other forms of exercises or manual therapy for acute and chronic LBP. Level of Evidence: 1