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

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

Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects

“…Since the design of the present study, the acceptance and understanding of FM has increased substantially worldwide, including within China, with more treatments available for FM in certain countries, 31–33 although data beyond the use of traditional Chinese medicines are still limited in native Chinese patients with FM. 14 , 34 , 35 With greater understanding, ACR diagnosis criteria have been updated and now focus on widespread pain (the widespread pain index [WPI]) alongside other symptoms (using measures such as the symptom severity scale), 8 , 9 rather than focusing on tender point analysis, which the present study used as part of the screening criteria for eligibility. 28 Updated 2010/2016 ACR guidelines have been validated in many countries, 36 although the importance of tender points in the diagnosis of FM is still debated by some.…”

Acupuntura Como Abordagem Terapêutica Para Fibromialgia: Uma Revisão Bibliográfica

“…A partir da análise bibliográfica, evidenciouse que as sessões de acupuntura culminaram em diminuição de pontos dolorosos e redução da escala visual analógica da dor (EVA) (BAI et al, 2014;CHINN et al, 2016;HAN et al, 2020;STIVAL et al, 2014). Além disso, exercícios físicos aeróbicos, quando associados à terapia multiprofissional da FM (incluindo-se a acupuntura), aumentam o limiar de dor dos pacientes e reduzem fadiga e rigidez (BAI et al, 2014;BIDONDE et al, 2017).…”

Acupuncture for comorbid mild-moderate depression and chronic musculoskeletal pain: study protocol for a randomized controlled trial

“…Participants in the SA group will receive the same procedure as the RA group but using non-insertion sham acupuncture [19] (Fig. 3).…”