Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial
Autor: | Jianyong Zhang, Qiu-wei Peng, Feng Tian, Quan Jiang, Xiao-po Tang, Yuya Xiao, Man Han, Donghong Xiao, Juan Jiao, Jiakang Cui |
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Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
China Fibromyalgia Time Factors Visual analogue scale Acupuncture Therapy Medicine (miscellaneous) Revised Fibromyalgia Impact Questionnaire Pain Traditional Chinese medicine law.invention Pittsburgh Sleep Quality Index 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial Primary fibromyalgia law Acupuncture Medicine Humans Multicenter Studies as Topic Pharmacology (medical) Medicine Chinese Traditional Fatigue Pain Measurement Randomized Controlled Trials as Topic 030203 arthritis & rheumatology Psychiatric Status Rating Scales lcsh:R5-920 business.industry Depression Patient Selection medicine.disease Clinical trial Treatment Outcome Patient Satisfaction Physical therapy Quality of Life lcsh:Medicine (General) business 030217 neurology & neurosurgery |
Zdroj: | Trials Trials, Vol 21, Iss 1, Pp 1-9 (2020) |
ISSN: | 1745-6215 |
Popis: | 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 |
Databáze: | OpenAIRE |
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