Dataset Information

Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials.

ABSTRACT:

Background

Blinding 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.

Methods

Twelve 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.

Results

The 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.

Discussion

The 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.

SUBMITTER: Braithwaite FA

PROVIDER: S-EPMC6074757 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials.

Braithwaite Felicity A FA Walters Julie L JL Li Lok Sze Katrina LSK Moseley G Lorimer GL Williams Marie T MT McEvoy Maureen P MP

PeerJ 20180731

<h4>Background</h4>Blinding 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, s ...[more]

PMID: 30083458

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Project description:BACKGROUND: Plantar heel pain (plantar fasciitis) is one of the most common musculoskeletal pathologies of the foot. Plantar heel pain can be managed with dry needling and/or injection of myofascial trigger points (MTrPs) however the evidence for its effectiveness is uncertain. Therefore, we aimed to systematically review the current evidence for the effectiveness of dry needling and/or injections of MTrPs associated with plantar heel pain. METHODS: We searched specific electronic databases (MEDLINE, EMBASE, AMED, CINAHL, SPORTDiscus and AMI) in April 2010 to identify randomised and non-randomised trials. We included trials where participants diagnosed with plantar heel pain were treated with dry needling and/or injections (local anaesthetics, steroids, Botulinum toxin A and saline) alone or in combination with acupuncture. Outcome measures that focussed on pain and function were extracted from the data. Trials were assessed for quality using the Quality Index tool. RESULTS: Three quasi-experimental trials matched the inclusion criteria: two trials found a reduction in pain for the use of trigger point dry needling when combined with acupuncture and the third found a reduction in pain using 1% lidocaine injections when combined with physical therapy. However, the methodological quality of the three trials was poor, with Quality Index scores ranging form 7 to 12 out of a possible score of 27. A meta-analysis was not conducted because substantial heterogeneity was present between trials. CONCLUSIONS: There is limited evidence for the effectiveness of dry needling and/or injections of MTrPs associated with plantar heel pain. However, the poor quality and heterogeneous nature of the included studies precludes definitive conclusions being made. Importantly, this review highlights the need for future trials to use rigorous randomised controlled methodology with measures such as blinding to reduce bias. We also recommend that such trials adhere to the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) to ensure transparency.

Project description:BackgroundPlantar heel pain (plantar fasciitis) is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain.MethodsEighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i) real dry needling or (ii) sham dry needling. The protocol (including needling details and treatment regimen) was formulated by general consensus (using the Delphi research method) using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two) and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version). Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle.ConclusionThis study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials and the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines. The findings from this trial will provide evidence for the effectiveness of trigger point dry needling for plantar heel pain.Trial registrationAustralian New Zealand 'Clinical Trials Registry'. ACTRN12610000611022.

Project description:Dry needling (DN) is a standard procedure for treating musculoskeletal disorders. However, there are no clear recommendations for using DN in low back pain (LBP). Therefore, this study aimed to assess the effectiveness of the novel DN program for reducing pain intensity and improving functional efficiency in patients with chronic LBP. A group of 40 patients with chronic LBP due to the L5-S1 discopathy were eligible and randomized into experimental (n = 20) and control (n = 20) groups. The DN program was performed for the experimental group according to the Five Regulatory Systems (FRS) concept. The control group received sham therapy using placebo needles. DN sessions were performed twice a week for 4 weeks. A single needling application lasted 60 min. Both groups received standard treatment and physical exercise of LBP for 1 month. Subjective pain was measured by a visual analog scale (VAS), functional efficiency was assessed with the Oswestry Disability Index (ODI), and the lower spine range of motion was measured with the Schober test. There were significant differences in pain reduction (VAS) in both groups (p < 0.001). The strongest analgesic effect in the DN group yielded 6.45 points immediately after the therapy, 6.2 points after 1 month, and 6 points after 3 months. The DN group scored higher VAS reduction than the control group (p < 0.001). There were significant differences in the functional state (ODI) in the experimental group (p < 0.001). There was a significant ODI decrease by 18.1 points, after 1 month by 18.9 points, and after 3 months by 17.6 points. No significant differences were found in the control group (p > 0.05). Intergroup differences were observed in the functional efficiency in ODI in all measurement time-points (p < 0.001). There were significant differences in the range of motion (Schober test) in the DN group (main effect: p < 0.001). For all measurements, differences (p < 0.001) were observed in favor of DN compared to the control. In conclusion, DN program according to the FRS concept stands for the novel treatment method supplemented by an exercise program, effectively reducing pain and improving functional efficiency in LBP patients.

Project description:Our aim was to evaluate the effect of dry needling alone as compared to sham needling, no intervention, or other physical interventions applied over trigger points (TrPs) related with neck pain symptoms. Randomized controlled trials including one group receiving dry needling for TrPs associated with neck pain were identified in electronic databases. Outcomes included pain intensity, pain-related disability, pressure pain thresholds, and cervical range of motion. The Cochrane risk of bias tool and the Physiotherapy Evidence Database (PEDro) score were used to assessed risk of bias (RoB) and methodological quality of the trials. The quality of evidence was assessed by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Between-groups mean differences (MD) and standardized mean differences (SMD) were calculated (3) Twenty-eight trials were finally included. Dry needling reduced pain immediately after (MD -1.53, 95% CI -2.29 to -0.76) and at short-term (MD -2.31, 95% CI -3.64 to -0.99) when compared with sham/placebo/waiting list/other form of dry needling and, also, at short-term (MD -0.51, 95% CI -0.95 to -0.06) compared with manual therapy. No differences in comparison with other physical therapy interventions were observed. An effect on pain-related disability at the short-term was found when comparing dry needing with sham/placebo/waiting list/other form of dry needling (SMD -0.87, 95% CI -1.60 to -0.14) but not with manual therapy or other interventions. Dry needling was effective for improving pressure pain thresholds immediately after the intervention (MD 55.48 kPa, 95% CI 27.03 to 83.93). No effect on cervical range of motion of dry needling against either comparative group was found. No between-treatment effect was observed in any outcome at mid-term. Low to moderate evidence suggests that dry needling can be effective for improving pain intensity and pain-related disability in individuals with neck pain symptoms associated with TrPs at the short-term. No significant effects on pressure pain sensitivity or cervical range of motion were observed. Registration number: OSF Registry-https://doi.org/10.17605/OSF.IO/P2UWD.

Dataset Information

Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials.

Background

Methods

Results

Discussion

Publications

Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials.

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