Pilot Study of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: warm acupunctrue

Study type: Interventional

Funder types: Other

Identifiers

NCT05228990

CI2021A015

Details and patient eligibility

About

Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
2. Be over 18 years of age;
3. The type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks;
4. The VAS score of item 10 (sensitivity to cold) in FIQR scale ≧4 points;
5. Sign informed consent.

Exclusion criteria

1. Patients suffering from systemic or local acute infectious diseases;
2. Patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment;
3. Pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Warm acupuncture - observation group

Experimental group

Description:

Sequence A: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks. Sequence B: Patients will be observed without any intervention for eight weeks.

Treatment:

Device: warm acupunctrue

Observation - warm acupuncture group

Experimental group

Description:

Sequence A: Patients will be observed without any intervention for eight weeks. Sequence B: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks.

Treatment:

Device: warm acupunctrue