Tasha R. Stanton

Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review

Background and Purpose: The methodological quality of randomized controlled trials (RCTs) is commonly evaluated in order to assess the risk of biased estimates of treatment effects. The purpose of this systematic review was to identify scales used to evaluate the methodological quality of RCTs in health care research and summarize the content, construction, development, and psychometric properties of these scales. Methods: Extensive electronic database searches, along with a manual search, were performed. Results: One hundred five relevant studies were identified. They accounted for 21 scales and their modifications. The majority of scales had not been rigorously developed or tested for validity and reliability. The Jadad Scale presented the best validity and reliability evidence; however, its validity for physical therapy trials has not been supported. Discussion and Conclusion: Many scales are used to evaluate the methodological quality of RCTs, but most of these scales have not been adequately developed and have not been adequately tested for validity and reliability. A valid and reliable scale for the assessment of the methodological quality of physical therapy trials needs to be developed.

Evidence for working memory deficits in chronic pain: A systematic review and meta-analysis

&NA; Pooled results from behavioural outcome measures of working memory show chronic pain is associated with impaired working memory. A consistent, moderate significant effect is shown in this systematic review and meta‐analysis of 24 studies. &NA; People with chronic pain commonly report impaired cognitive function. However, to date, there has been no systematic evaluation of the body of literature concerning cognitive impairment and pain. Nor have modern meta‐analytical methods been used to verify and clarify the extent to which cognition may be impaired. The objective of this study was to systematically evaluate and critically appraise the literature concerning working memory function in people with chronic pain. The study was conducted along Cochrane collaboration and Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement guidelines. A sensitive search strategy was designed and conducted with the help of an expert librarian using 6 databases. Twenty‐four observational studies evaluating behavioural and/or physiological outcomes in a chronic pain group and a control group met the inclusion criteria. All studies had a high risk of bias, owing primarily to lack of assessor blinding to outcome. High heterogeneity within the field was found with the inclusion of 24 papers using 21 different working memory tests encompassing 9 different working memory constructs and 9 different chronic pain populations. Notwithstanding high heterogeneity, pooled results from behavioural outcomes reflected a consistent, significant moderate effect in favour of better performance by healthy controls and, with the exception of one study, pooled results from physiological outcomes reflected no evidence for an effect. Future research would benefit from the use of clearly defined constructs of working memory, as well as standardised methods of testing.

After an episode of acute low back pain, recurrence is unpredictable and not as common as previously thought

Study Design. Inception cohort study. Objective. To provide the first reliable estimate of the 1-year incidence of recurrence in subjects recently recovered from acute nonspecific low back pain (LBP) and to determine factors predictive of recurrence in 1 year. Summary of Background Data. Previous studies provide potentially flawed estimates of recurrence of LBP because they do not restrict the cohort to those who have recovered and are therefore eligible for a recurrence. Methods. We identified 1334 consecutive patients who presented to primary care with acute LBP; of these 353 subjects recovered before 6 weeks and entered the current study. The primary outcome measure was recurrence of LBP in the next year. Specifically, an episode of recurrence was defined in 2 ways: recall of recurrence at the 12-month follow-up and report of pain at the 3- or 12-month follow-up. Risk factors for recurrence were assessed at baseline. Pain intensity was assessed at 6 weeks, 3 months, and 12 months and recurrence at 12 months. Factors that could plausibly affect recurrence were chosen a priori and evaluated using a multivariable regression analysis. Results. Recurrence of LBP was found to be much less common than previous estimates suggest, ranging from 24% (95% CI = 20%–28%) using “12-month recall” definition of recurrence, to 33% (95% CI = 28%–38%) using “pain at follow-up” definition of recurrence. However, only 1 factor, previous episode(s) of LBP, was consistently predictive of recurrence within the next 12 months (odds ratio = 1.8–2.0, P = 0.00–0.05). Conclusion. This study challenges the assumption that the majority of subjects will have a recurrence of LBP in a 1-year period. After the resolution of an episode of acute LBP, about 25% of subjects will have a recurrence in the next year. It is difficult to predict who will have a recurrence within the next year.

Inflammation in complex regional pain syndrome A systematic review and meta-analysis

ABSTRACT Objectives: We conducted a systematic review of the literature with meta-analysis to determine whether complex regional pain syndrome (CRPS) is associated with a specific inflammatory profile and whether this is dependent on the duration of the condition. Methods: Comprehensive searches of the literature using MEDLINE, Embase, Scopus, Web of Science, and reference lists from published reviews identified articles that measured inflammatory factors in CRPS. Two independent investigators screened titles and abstracts, and performed data extraction and risk of bias assessments. Studies were subgrouped by medium (blood, blister fluid, and CSF) and duration (acute and chronic CRPS). Where possible, meta-analyses of inflammatory factor concentrations were performed and pooled effect sizes were calculated using random-effects models. Results: Twenty-two studies were included in the systematic review and 15 in the meta-analysis. In acute CRPS, the concentrations of interleukin (IL)-8 and soluble tumor necrosis factor receptors I (sTNF-RI) and II (sTNF-RII) were significantly increased in blood. In chronic CRPS, significant increases were found in 1) TNFα, bradykinin, sIL-1RI, IL-1Ra, IL-2, sIL-2Ra, IL-4, IL-7, interferon-γ, monocyte chemoattractant protein-1 (MCP-1), and sRAGE (soluble receptor for advanced glycation end products) in blood; 2) IL-1Ra, MCP-1, MIP-1β, and IL-6 in blister fluid; and 3) IL-1β and IL-6 in CSF. Chronic CRPS was also associated with significantly decreased 1) substance P, sE-selectin, sL-selectin, sP-selectin, and sGP130 in blood; and 2) soluble intercellular adhesion molecule-1 (sICAM-1) in CSF. Most studies failed to meet 3 or more of our quality criteria. Conclusion: CRPS is associated with the presence of a proinflammatory state in the blood, blister fluid, and CSF. Different inflammatory profiles were found for acute and chronic cases.

Effect of Motor Control Exercises Versus Graded Activity in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Background Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other. Objective The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain. Design This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group. Setting The study was conducted in primary care settings. Patients The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain. Interventions Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy. Measurements Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention. Results A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (−0.7 to 0.8). Limitations Clinicians could not be blinded to the interventions. Conclusion The results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.

Evaluation of a Treatment-Based Classification Algorithm for Low Back Pain: A Cross-Sectional Study

Background Several studies have investigated criteria for classifying patients with low back pain (LBP) into treatment-based subgroups. A comprehensive algorithm was created to translate these criteria into a clinical decision-making guide. Objective This study investigated the translation of the individual subgroup criteria into a comprehensive algorithm by studying the prevalence of patients meeting the criteria for each treatment subgroup and the reliability of the classification. Design This was a cross-sectional, observational study. Methods Two hundred fifty patients with acute or subacute LBP were recruited from the United States and Australia to participate in the study. Trained physical therapists performed standardized assessments on all participants. The researchers used these findings to classify participants into subgroups. Thirty-one participants were reassessed to determine interrater reliability of the algorithm decision. Results Based on individual subgroup criteria, 25.2% (95% confidence interval [CI]=19.8%–30.6%) of the participants did not meet the criteria for any subgroup, 49.6% (95% CI=43.4%–55.8%) of the participants met the criteria for only one subgroup, and 25.2% (95% CI=19.8%–30.6%) of the participants met the criteria for more than one subgroup. The most common combination of subgroups was manipulation + specific exercise (68.4% of the participants who met the criteria for 2 subgroups). Reliability of the algorithm decision was moderate (kappa=0.52, 95% CI=0.27–0.77, percentage of agreement=67%). Limitations Due to a relatively small patient sample, reliability estimates are somewhat imprecise. Conclusions These findings provide important clinical data to guide future research and revisions to the algorithm. The finding that 25% of the participants met the criteria for more than one subgroup has important implications for the sequencing of treatments in the algorithm. Likewise, the finding that 25% of the participants did not meet the criteria for any subgroup provides important information regarding potential revisions to the algorithms bottom table (which guides unclear classifications). Reliability of the algorithm is sufficient for clinical use.

Social Media Release Increases Dissemination of Original Articles in the Clinical Pain Sciences

A barrier to dissemination of research is that it depends on the end-user searching for or ‘pulling’ relevant knowledge from the literature base. Social media instead ‘pushes’ relevant knowledge straight to the end-user, via blogs and sites such as Facebook and Twitter. That social media is very effective at improving dissemination seems well accepted, but, remarkably, there is no evidence to support this claim. We aimed to quantify the impact of social media release on views and downloads of articles in the clinical pain sciences. Sixteen PLOS ONE articles were blogged and released via Facebook, Twitter, LinkedIn and ResearchBlogging.org on one of two randomly selected dates. The other date served as a control. The primary outcomes were the rate of HTML views and PDF downloads of the article, over a seven-day period. The critical result was an increase in both outcome variables in the week after the blog post and social media release. The mean ± SD rate of HTML views in the week after the social media release was 18±18 per day, whereas the rate during the other three weeks was no more than 6±3 per day. The mean ± SD rate of PDF downloads in the week after the social media release was 4±4 per day, whereas the rate during the other three weeks was less than 1±1 per day (p<0.05 for all comparisons). However, none of the recognized measures of social media reach, engagement or virality related to either outcome variable, nor to citation count one year later (p>0.3 for all). We conclude that social media release of a research article in the clinical pain sciences increases the number of people who view or download that article, but conventional social media metrics are unrelated to the effect.

Primary Somatosensory Cortex Function in Complex Regional Pain Syndrome: A Systematic Review and Meta-Analysis

UNLABELLED That complex regional pain syndrome (CRPS) is associated with functional reorganization in the primary somatosensory cortex (S1) is widely accepted and seldom questioned. Despite more than a decade of research, there has been no systematic review of the CRPS literature concerning the changes in S1 function, and therefore the extent of these changes is unclear. Here we conduct a systematic review and meta-analysis to quantify the spatial and temporal aspects of S1 function in CRPS. A comprehensive search strategy identified functional neuroimaging studies of S1 in CRPS. We adhered to a rigorous systematic review protocol when extracting data and appraising risk of bias. Outcomes were grouped into spatial representation; activation levels, including disinhibition; peak latency of activation; and glucose metabolism. Meta-analysis was conducted where possible. Fifteen studies were included, all investigating upper-extremity CRPS. In patients with CRPS, the S1 spatial representation of the affected hand is smaller than that of the unaffected hand and that of non-CRPS controls; however, this evidence comes from only a few studies. There is no difference in activation, disinhibition, or latency of peripherally evoked S1 responses in CRPS. The risk of bias was high across studies, mainly from unclear sampling methods and unblinded analysis of outcomes. PERSPECTIVE The evidence for a difference in function of the primary somatosensory cortex in CRPS compared with controls is clouded by high risk of bias and conflicting results, but reduced representation size seems consistent.

Critical Appraisal of Clinical Prediction Rules That Aim to Optimize Treatment Selection for Musculoskeletal Conditions

Background Clinical prediction rules (CPRs) for treatment selection in musculoskeletal conditions have become increasingly popular. Purpose The purposes of this review are: (1) to critically appraise studies evaluating CPRs and (2) to consider the clinical utility and stage of development of each CPR. Data Sources Pertinent databases were searched up to April 2009. Studies aiming to develop or evaluate a CPR for treatment response in musculoskeletal conditions were included. Two independent reviewers assessed eligibility and extracted methodological data, stage of development, and effect size information. Study Selection/Data Extraction and Synthesis Eighteen studies, evaluating 15 separate CPRs, were included. Fourteen CPRs were at the derivation stage, and all CPRs had been evaluated using a single-arm trial design, thus it is not possible to determine whether the CPRs identify prognosis (regardless of treatment) or specifically response to treatment. The CPR at the validation stage investigated spinal manipulative therapy (SMT) for low back pain and had been evaluated in 2 separate well-conducted randomized controlled trials. The first trial demonstrated a clinically meaningful effect of the SMT CPR; the additional effect from SMT in patients “positive-on-the-rule” was 15 Oswestry disability units at week 1 and 9 units at week 4. The second trial showed that the CPR did not generalize to a different clinical setting, including a modified treatment. Limitations Due to differences in methods of reporting and journal publication restraints (eg, word count restrictions), some quality assessment items may have been completed in the included studies, but not captured in this review. Conclusions There is, at present, little evidence that CPRs can be used to predict effects of treatment for musculoskeletal conditions. The principal problem is that most studies use designs that cannot differentiate between predictors of response to treatment and general predictors of outcome. Only 1 CPR has been evaluated within an RCT designed to predict response to treatment. Validation of these rules is imperative to allow clinical application.

Do people with chronic pain have impaired executive function? A meta-analytical review

A widely held belief within the clinical community is that chronic pain is associated with cognitive impairment, despite the absence of a definitive systematic review or meta-analysis on the topic. The current systematic review and meta-analysis aimed to establish the current evidence concerning the difference in executive function between people with chronic pain and healthy controls. Six databases were searched for citations related to executive function and chronic pain from inception to June 24, 2013. Two reviewers independently assessed studies for eligibility and extracted relevant data according to the Cochrane Collaboration and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Twenty five studies were included in the review and twenty two studies in the meta-analysis. A small to moderate impairment in executive function performance was found in people with chronic pain across cognitive components, although all studies had a high risk of bias. The current evidence suggests impairment of executive function in people with chronic pain, however, important caveats exist. First, executive function involves many cognitive components and there is no standard test for it. Second, moderators of executive function, such as medication and sleep, were seldom controlled for in studies of executive function performance.