Trial reportJournal of alternative and complementary medicine (New York, N.Y.)2008
Development of protocols for randomized sham-controlled trials of complex treatment interventions: Japanese acupuncture for endometriosis-related pelvic pain.
Trial report in Journal of alternative and complementary medicine (New York, N.Y.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.Journal of alternative and complementary medicine (New York, N.Y.) · 2019Pooled it
- Acupuncture for pain in endometriosis.The Cochrane database of systematic reviews · 2011Pooled it
- Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.PLoS medicine · 2010 · on this mapGuideline
- Trial
- Trial
- Acupuncturist perceptions of serving as a clinical trial practitioner.Complementary therapies in medicine · 2012Trial
- Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial.Contemporary clinical trials · 2012Trial
- Feasibility trial of electroacupuncture for aromatase inhibitor--related arthralgia in breast cancer survivors.Integrative cancer therapies · 2009Trial
- An innovative acupuncture treatment for primary dysmenorrhea: a randomized, crossover pilot study.Alternative therapies in health and medicineTrial
- Acupuncture for Anxiety, Depression, and Sleep in Veterans with Combat-Related Posttraumatic Stress Disorder: A Randomized Controlled Trial.Journal of clinical medicine · 2025Article
- Article
- Acupuncture for endometriosis: A systematic review and meta-analysis.Integrative medicine research · 2023Review
- Development of Provisional Acupuncture Guidelines for Pelvic Pain in Endometriosis Using an e-Delphi Consensus Process.Journal of integrative and complementary medicine · 2023Article
- Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process.Acupuncture in medicine : journal of the British Medical Acupuncture Society · 2022Article
- The Assessment and Treatment of Inpatient Cancer-Related Pain with Acupuncture: Development of a Manual.Medical acupuncture · 2022Article
- The Role of Research in Guiding Treatment for Women's Health: A Qualitative Study of Traditional Chinese Medicine Acupuncturists.International journal of environmental research and public health · 2021Article
- Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.Global advances in health and medicine · 2021Article
- Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial.BMJ open · 2019Article
- A Double-Blind Study on Acupuncture Sensations with Japanese Style of Acupuncture: Comparison between Penetrating and Placebo Needles.Evidence-based complementary and alternative medicine : eCAM · 2018Article
- Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial.BMC complementary and alternative medicine · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundVery little research has been conducted in the West to evaluate the clinical efficacy of Japanese acupuncture (JA). The characteristics that define and differentiate JA from Chinese acupuncture styles add specific challenges to the operationalization of treatment protocols for use in clinical trials.
objectivesTo develop an ecologically valid and viable multimodal treatment intervention, including active and sham protocols, for use in a pilot randomized sham-controlled trial of a style of JA in treating endometriosis-related chronic pelvic pain in adolescents and young women.
methodsA focus group format was used to systematize the diagnostic framework, operationalize the intake, design the treatment protocols, and develop a viable and effective sham acupuncture intervention using the Streitberger device and sham moxibustion. Implementation of the treatment protocol employed the manualization process to provide flexibility of treatment while assuring replicability and standardization.
settingThe Japanese Acupuncture Department at the New England School of Acupuncture in Newton, MA.
resultsCompleted study visit forms indicated good compliance of study practitioners with active and sham treatment protocols. The specific JA protocols used in our pilot study were well tolerated by the adolescent girls who participated in the trial. No serious adverse events were reported by any participants. Our protocols were successful in maintaining patient blinding and minimizing differences in outcome expectations between treatment groups.
conclusionsManualization provided a viable method for conforming to the interactive nature of JA treatments, yet facilitated compliance with a replicable treatment protocol. Sham controls of complex, multicomponent JA interventions pose unique challenges. The modified Streitberger needle in conjunction with sham moxibustion showed promise as a viable control in clinical trails of JA; both components of this sham protocol require further validation.
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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.