A clinical trial will be conducted to validate the safety and efficacy of acupuncture on the management of FM (fibromyalgia). The trial results may yield significant clinical evidence on the therapeutic effects of acupuncture therapy to treat patients with FM.

In traditional Chinese medicine, acupuncture as a nonpharmacological therapy is well recognized for its unique beneficial effect for several diseases. However, whether acupuncture therapy can effectively treat FM is uncertain.

A randomized, blinded, placebo-controlled trial of two cohorts will be conducted to determine the effectiveness of acupuncture for patients with FM. This may aid to alleviate the clinical symptoms and enhance the patients’ quality of life.

At Shenzhen Traditional Chinese Medicine Hospital and Guang’anmen Hospital of China Academy of Chinese Medical Sciences, this two-center analysis will be carried out. The study will recruit a total of 68 patients with primary FM, diagnosed with the American College of Rheumatology criteria. Participants will be randomized (1:1 ratio) to either acupuncture or sham acupuncture group. For 8 weeks, all the enrolled FM patients will be given acupuncture therapy with follow-up examinations every 4 weeks for 16 weeks. Trial design is presented in Figure.

Trial flow and study design. General information = name, gender, age, height, weight, duration of illness, smoking history, drinking history, education, job, family income. 1st outcome = pain-VAS, Revised Fibromyalgia Impact Questionnaire (FIQR). 2nd outcome = Multidimensional Assessment of Fatigue scale (MAF), SF-36, pss-14, Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), changes in the number of 18 tender points. 3rd outcome = Patient satisfaction for the treatment (PGIC)

Utilizing VAS (visual analogue scale) and revised FIQR (fibromyalgia impact questionnaire) for pain intensity, the primary endpoints will be estimated. The secondary endpoints will incorporate, SF-36 (Short Form-36), MAF (Multidimensional Assessment of Fatigue scale), BDI (Beck Depression Inventory), pss-14 (Chinese perceived stress scales), changes in the number of 18 tender points, PSQI (Pittsburgh Sleep Quality Index), patient satisfaction for the treatment and adverse effects.

The recruitment of patients will be completed in August 2020. The study is anticipated to finish in December 2020.