BackgroundBlinding is critical to clinical trials because it allows for separation of specific intervention effects from bias, by equalising all factors between groups except for the proposed mechanism of action. Absent or inadequate blinding in clinical trials has consistently been shown in large meta-analyses to result in overestimation of intervention effects. Blinding in dry needling trials, particularly blinding of participants and therapists, is a practical challenge; therefore, specific effects of dry needling have yet to be determined. Despite this, dry needling is widely used by health practitioners internationally for the treatment of pain. This review presents the first empirical account of the influence of blinding on intervention effect estimates in dry needling trials. The aim of this systematic review was to determine whether participant beliefs about group allocation relative to actual allocation (blinding effectiveness), and/or adequacy of blinding procedures, moderated pain outcomes in dry needling trials.MethodsTwelve databases (MEDLINE, EMBASE, AMED, Scopus, CINAHL, PEDro, The Cochrane Library, Trove, ProQuest, trial registries) were searched from inception to February 2016. Trials that compared active dry needling with a sham that simulated dry needling were included. Two independent reviewers performed screening, data extraction, and critical appraisal. Available blinding effectiveness data were converted to a blinding index, a quantitative measurement of blinding, and meta-regression was used to investigate the influence of the blinding index on pain. Adequacy of blinding procedures was based on critical appraisal, and subgroup meta-analyses were used to investigate the influence of blinding adequacy on pain. Meta-analytical techniques used inverse-variance random-effects models.ResultsThe search identified 4,894 individual publications with 24 eligible for inclusion in the quantitative syntheses. In 19 trials risk of methodological bias was high or unclear. Five trials were adequately blinded, and blinding was assessed and sufficiently reported to compute the blinding index in 10 trials. There was no evidence of a moderating effect of blinding index on pain. For short-term and long-term pain assessments pooled effects for inadequately blinded trials were statistically significant in favour of active dry needling, whereas there was no evidence of a difference between active and sham groups for adequately blinded trials.DiscussionThe small number and size of included trials meant there was insufficient evidence to conclusively determine if a moderating effect of blinding effectiveness or adequacy existed. However, with the caveats of small sample size, generally unclear risk of bias, statistical heterogeneity, potential publication bias, and the limitations of subgroup analyses, the available evidence suggests that inadequate blinding procedures could lead to exaggerated intervention effects in dry needling trials.

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Background Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. Purpose The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. Data Sources Twelve databases were searched from inception to February 2016. Study Selection Trials that compared active dry needling with a sham that simulated dry needling were included. Data Extraction The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). Data Synthesis The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. Limitations Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. Conclusions Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.

BackgroundThe presence of comorbid conditions could impact performance in pulmonary rehabilitation (PR) programmes. We aimed to compare the comorbidity prevalence among those with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) and evaluate the impact on PR response.MethodsWe performed a retrospective cohort study, recording comorbidities for all patients with COPD or ILD referred to PR. Participants were classified as responders to PR if they met the minimal important difference for exercise capacity and health-related quality of life (HRQoL). The prevalence of comorbidities and impact on PR outcomes were compared by lung disease and by sex using a univariate analysis and multivariate logistic regression.ResultsThe mean number of comorbidities was similar among those with COPD (3.3±2.1, n=242) and ILD (3.2±1.9, n=66) (p>0.05). Females had a higher number of comorbidities than males in both COPD (p=0.001) and ILD (p=0.017) populations. Circulatory (64%) and endocrine/metabolic (45%) conditions were most common in COPD. In ILD, digestive (55%) and circulatory (53%) comorbidities were most prevalent. In people with ILD, those over 65 years, with musculoskeletal/connective tissue disease or circulatory disease were less likely to obtain meaningful improvements in exercise capacity. There was no impact of comorbidities on exercise capacity in COPD or on HRQoL in ILD.ConclusionsThe majority of patients with COPD or ILD enrolled in PR programmes have multiple comorbidities that may affect improvements in exercise capacity. PR programmes may be less effective for older adults with ILD and comorbid circulatory or musculoskeletal disease.

Counseling has been suggested as a promising approach for facilitating changes in health behavior. The aim of this systematic review of counseling interventions for people with COPD was to describe: 1) counseling definitions, 2) targeted health behaviors, 3) counseling techniques and 4) whether commonalities in counseling techniques were associated with improved health behaviors. Ten databases were searched for original randomized controlled trials which included adults with COPD, used the term “counseling” as a sole or component of a multifaceted intervention and were published in the previous 10 years. Data extraction, study appraisal and coding for behavior change techniques (BCTs) were completed by two independent reviewers. Data were synthesized descriptively, with meta-analysis conducted where possible. Of the 182 studies reviewed as full-text, 22 were included. A single study provided a definition for counseling. Two key behaviors were the main foci of counseling: physical activity (n=9) and smoking cessation (n=8). Six studies (27%) reported underlying models and/or theoretical frameworks. Counseling was the sole intervention in 10 studies and part of a multicomponent intervention in 12. Interventions targeting physical activity included a mean of 6.3 (±3.1) BCTs, smoking cessation 4.9 (±2.9) BCTs and other behaviors 6.5 (±3.9) BCTs. The most frequent BCTs were social support unspecified (n=22; 100%), goal setting behavior (n=11), problem-solving (n=11) and instructions on how to perform the behavior (n=10). No studies shared identical BCT profiles. Counseling had a significant positive effect for smoking cessation and positive but not significant effect for physical activity. Counseling for health behavior change was rarely defined and effectiveness varied by target behavior. Provision of specific details when reporting studies of counseling interventions (definition, BCTs, dosage) would allow clarification of the effectiveness of counseling as an approach to health behavior change in people with COPD.