Abstract
BackgroundAcupuncture 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.MethodsThe 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.DiscussionThis 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 registrationChinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://www.acmctr.org/listbycreater.aspx
Highlights
Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM)
Primary fibromyalgia (FM) is a chronic clinical condition characterized by diffuse pain and stiffness as the major clinical feature, which is often accompanied by fatigue, weakness, sleep disorders, emotional abnormalities, and cognitive dysfunction [1]
The etiology of FM remains unclear, it is currently considered that both neuroendocrine changes and immune dysregulations are involved in the pathogenesis of this disease [3]
Summary
Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). Whether acupuncture can effectively treat fibromyalgia is currently unclear. 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. Current treatments of FM mainly include pharmacotherapy and nonpharmacologic therapy. The available treatments in traditional Chinese medicine (TCM) comprise diverse and effective nonpharmacologic therapies such as acupuncture, massage, cupping, tai chi, and qi gong. The newly revised FM treatment recommendations by EULAR have placed acupuncture as one of the specific recommendations for the nonpharmacologic therapies since acupuncture has been shown to alleviate pain, relieve fatigue, and improve the quality of life in patients with FM [7]
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