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

Judith M Schlaeger1, Nobuari Takakura2, Hiroyoshi Yajima2

  • 11Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, 845 S. Damen (M/C 802), Chicago, IL 60612 USA.

Pilot and Feasibility Studies
|April 25, 2018
PubMed
Summary
This summary is machine-generated.

This pilot study shows a 13-needle, 10-session acupuncture protocol is feasible for vulvodynia research. The method successfully enrolled participants and maintained high adherence and acceptability for future double-blind trials.

Keywords:
AcupunctureDouble-blind acupuncture needlesPainPlaceboProvoked vestibulodyniaVulvar vestibulitisVulvodynia

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Area of Science:

  • Integrative medicine and pain management research.
  • Clinical trial methodology and feasibility studies.

Background:

  • Establishing efficacy for acupuncture requires robust double-blind methods.
  • Previous double-blind acupuncture studies were limited to single sessions and fewer needles.

Purpose of the Study:

  • To determine the feasibility of a 13-needle, 10-session acupuncture protocol in a double-blind randomized controlled pilot study.
  • To assess participant enrollment, retention, protocol adherence, and acceptability.

Main Methods:

  • A double-blind randomized controlled pilot study involving 6 women with vulvodynia.
  • Participants were randomized to either a penetrating needle group or a skin-touch placebo control group.
  • Feasibility was assessed through participant enrollment, retention, acupuncturist adherence, and participant-reported outcomes.

Main Results:

  • All 6 participants completed the 10-session protocol over 5 weeks with 100% attendance.
  • Acupuncturists flawlessly administered the protocol, with no needle malfunctions.
  • Participant acceptability was high, with a mean score of 93.3%.

Conclusions:

  • The 13-needle, 10-session acupuncture protocol is feasible for use in a double-blind efficacy trial.
  • This validated protocol supports further research into acupuncture for vulvodynia.