Evidence map›Paper›PMID 32650673›Full record

ArticleClinical trials (London, England)2020

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

Alana D Steffen, Larisa A Burke, Heather A Pauls, Marie L Suarez, Yingwei Yao, William H Kobak, Miho Takayama, Hiroyoshi Yajima, Ted J Kaptchuk, Nobuari Takakura and 2 more

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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

12 authors at 4 institutions in 2 countries.

Alana D SteffenDepartment of Health Systems Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Larisa A BurkeOffice of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Heather A PaulsOffice of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Marie L SuarezDepartment of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Yingwei YaoDepartment of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.
William H KobakDepartment of Obstetrics and Gynecology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.
Miho TakayamaDepartment of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.
Hiroyoshi YajimaDepartment of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.
Ted J KaptchukProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Nobuari TakakuraDepartment of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.
Diana J WilkieDepartment of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.
Judith M SchlaegerDepartment of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.ORCID 0000-0002-3754-6176
University of Illinois Chicago · USTokyo Ariake University of Medical and Health Sciences · JPUniversity of Florida · USBeth Israel Deaconess Medical Center · 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

backgroundClinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.

methodsRandomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.

resultsAt present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Indexed as

Acupuncture TherapyAwards and PrizesClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansModels, StatisticalNeedlesRandomized Controlled Trials as TopicResearch DesignTranslational Research, BiomedicalVulvodyniaAcupunctureblindingclinical translational sciencedouble-blind sham acupuncturerandomizationrandomized controlled trialResearch Electronic Data Capturevulvodynia

Identifiers

PMID32650673
PMCPMC7529889
OpenAlexW3041844515

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.