Evidence map›Paper›PMID 29686883›Full record

ArticlePilot and feasibility studies2018

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

Judith M Schlaeger, Nobuari Takakura, Hiroyoshi Yajima, Miho Takayama, Alana D Steffen, Elizabeth M Gabzdyl, Robyn A Nisi, Kathleen McGowan Gruber, Jason M Bussell, Diana J Wilkie

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02704234 (Acupuncture for Vulvodynia), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02704234 nacompletednot on this map

Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study

TypeinterventionalSponsorUniversity of Illinois at ChicagoRan2018 to 2022Enrolled6ConditionsVulvodynia, Vulvar Vestibulitis, Dyspareunia, PainArmsActive Acupuncture, Placebo Acupuncture
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Evaluation and Treatment of Vulvodynia: State of the Science.Journal of midwifery & women's health · 2023
    Review
  7. Protocol for double-blind RCT of acupuncture for vulvodynia.Contemporary clinical trials communications · 2022
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Judith M Schlaeger1Department 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.ORCID 0000-0002-3754-6176
Nobuari Takakura2Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan.
Hiroyoshi Yajima2Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan.
Miho Takayama2Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan.
Alana D Steffen1Department 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.
Elizabeth M Gabzdyl1Department 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.
Robyn A Nisi1Department 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.
Kathleen McGowan Gruber1Department 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.
Jason M Bussell3Bloomberg School of Public Health, Johns Hopkins University, 615 N. Wolfe Street, Baltimore, MD 21205 USA.
Diana J Wilkie4Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, 1225 Center Drive, Gainesville, FL 32610 USA.
University of Illinois Chicago · USTokyo Ariake University of Medical and Health Sciences · JPJohns Hopkins University · USUniversity of Florida · US

Funding

Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia OutcomesR01HD091210 · NICHD · UNIVERSITY OF ILLINOIS AT CHICAGO · PI SCHLAEGER, JUDITH MICHELLE · 2017 to 2021
$2.0M
NICHD NIH HHS R01 HD091210
6 · The paper itself

Abstract

backgroundEfficacy 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.

methodsWe 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.

resultsSix 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%.

conclusionStudy feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia.

trial registrationClinicalTrials.gov, NCT02704234. Registered 30 November 2015.

Indexed as

AcupunctureDouble-blind acupuncture needlesPainPlaceboProvoked vestibulodyniaVulvar vestibulitisVulvodynia

Identifiers

PMID29686883
PMCPMC5897935
OpenAlexW2801562940

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.