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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.
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.
This study aims to analyze the effects of Dry Needling (DN) for the release of myofascial trigger points (MTrPs) in the triceps surae muscles (TSM). A systematic review was performed up to February 2022 in PubMed, PEDro, Scopus, CENTRAL, and Web of Science. Selection criteria were studies involving subjects older than 18 years presenting MTrPs in the TSM, without any concomitant acute or chronic musculoskeletal conditions; DN interventions applied to the MTrPs of the TSM; and results on pain, range of motion (ROM), muscle strength, muscle stiffness, and functional outcomes. The PEDro scale was used to assess the methodological quality of the studies, and the Risk of Bias Tool 2.0 to assess risk of bias. A total of 12 studies were included in the systematic review, involving 426 participants. These results suggest that DN of MTrPs in TSM could have a positive impact on muscle stiffness and functional outcomes. There are inconclusive findings on musculoskeletal pain, ROM, and muscle strength. Significant results were obtained in favor of the control groups on pressure pain thresholds. Despite the benefits obtained on muscle stiffness and functional performance, the evidence for the use of DN of MTrPs in the TSM remains inconclusive.
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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