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Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study.

ABSTRACT: Background:Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions. Methods:We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a double-blind, multi-needle, multi-session protocol; (3) participants completing measures; and (4) protocol acceptability to participants. In this double-blind randomized controlled pilot study, participants were randomized 1:1 to a penetrating needle group or a skin-touch placebo control group. Results:Six women with vulvodynia (mean age 31.5?±?8 years; five white, non-Latina, one black/African American) met the eligibility requirements, consented to participation, and were enrolled. All six participants (100%) completed the 10-session study protocol in 5 weeks without missing any treatment sessions. Per observed checklist documented technique, two acupuncturists flawlessly administered the 13-needle, 10-session acupuncture protocol; no needles malfunctioned. Six participants attended all sessions and completed 99% of measurement items. One participant did not like acupuncture (60% acceptability score) and five liked acupuncture (100% acceptability scores); the mean acceptability score was 93.3%. Conclusion:Study feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia. Trial registration:ClinicalTrials.gov, NCT02704234. Registered 30 November 2015.

SUBMITTER: Schlaeger JM

PROVIDER: S-EPMC5897935 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study.

Schlaeger Judith M JM Takakura Nobuari N Yajima Hiroyoshi H Takayama Miho M Steffen Alana D AD Gabzdyl Elizabeth M EM Nisi Robyn A RA McGowan Gruber Kathleen K Bussell Jason M JM Wilkie Diana J DJ

Pilot and feasibility studies 20180413

<h4>Background</h4>Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions.<h4>Methods</h4>We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a do ...[more]

PMID: 29686883

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Project description:BACKGROUND:The aim of this study was to compare the short-term and intermediate-term efficacy of acupuncture plus fire needle therapy with that of acupuncture alone in the treatment of lateral epicondylitis (LE). METHODS:Thirty-eight patients with LE who had persisted for at least 2 months were enrolled in this prospective, assessor-blinded, randomized controlled pilot trial. Twenty-one patients were randomized to the acupuncture plus fire needle group and 17 to the acupuncture-only group. The primary outcome was the visual analog scale pain score for the previous 24?hours and the secondary outcomes were the maximum grip strength, Patient-rated Forearm Evaluation Questionnaire score, and Medical Outcomes Study 36-Item Short-form Health Survey score. The values at baseline (pretreatment), at the end of treatment, and at 3 months after treatment were used to assess the short-term and intermediate-term effects of treatment. The data were analyzed using the Chi-square test and t test. RESULTS:Within-group analyses showed better results for acupuncture plus fire needle therapy in the short term and intermediate term. Differences in the severity of pain and secondary outcomes were significant in the intermediate term in the acupuncture group. At the end of treatment, none of the differences in outcome scores were significant, except for maximum grip strength in the affected hand in the acupuncture group. No significant between-group differences in short-term or intermediate-term outcomes were observed. CONCLUSION:Acupuncture plus fire needle therapy was effective in the short term in patients seeking improvement of LE. Twelve treatments were effective for relieving pain and improving disability in the intermediate term in patients with chronic LE in both study groups. The findings of the pilot study confirm the feasibility of proceeding to a larger randomized controlled study of the longer-term effects of acupuncture plus fire needle therapy in patients with LE.

Dataset Information

Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study.

Publications

Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study.

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