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

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...

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Detalles Bibliográficos
Autores principales: Schlaeger, Judith M., Takakura, Nobuari, Yajima, Hiroyoshi, Takayama, Miho, Steffen, Alana D., Gabzdyl, Elizabeth M., Nisi, Robyn A., McGowan Gruber, Kathleen, Bussell, Jason M., Wilkie, Diana J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5897935/
https://www.ncbi.nlm.nih.gov/pubmed/29686883
http://dx.doi.org/10.1186/s40814-018-0265-9
Descripción
Sumario: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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0265-9) contains supplementary material, which is available to authorized users.