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
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
Externí odkaz: