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Published in: Trials 1/2020

Open Access 01-12-2020 | Acupuncture | Study protocol

Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial

Authors: Man Han, Jiakang Cui, Yuya Xiao, Donghong Xiao, Juan Jiao, Qiuwei Peng, Feng Tian, Xiaopo Tang, Jianyong Zhang, Quan Jiang

Published in: Trials | Issue 1/2020

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Abstract

Background

Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibromyalgia is currently unclear. Therefore, we aim to design a study protocol of a randomized controlled clinical trial and assess the effectiveness of acupuncture for patients with fibromyalgia, which may lead to alleviation of clinical symptoms and improvement of patients’ quality of life.

Methods

The study is designed as a randomized, blinded, placebo-controlled trial of two cohorts conducted at Guang’anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively. A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups. All subjects will receive acupuncture intervention for 8 weeks with follow-up assessments every 4 weeks for 16 weeks. The primary outcome will be evaluated using the visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity. The secondary outcome measures will include: Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events. The mentioned outcome measurements will be assessed every 4 weeks for 6 months.

Discussion

This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia. The results of this trial may provide clinical evidence on the beneficial effects of acupuncture in treating fibromyalgia.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://​www.​acmctr.​org/​listbycreater.​aspx
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Metadata
Title
Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial
Authors
Man Han
Jiakang Cui
Yuya Xiao
Donghong Xiao
Juan Jiao
Qiuwei Peng
Feng Tian
Xiaopo Tang
Jianyong Zhang
Quan Jiang
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04317-y

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