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

NCT ID: NCT05228990

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2023-12-31

Brief Summary

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 .

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Warm acupuncture - observation group

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.

Group Type: EXPERIMENTAL

warm acupunctrue

Intervention Type: DEVICE

The sterile acupuncture needle (0.3mm×40mm) is taken, and the acupuncture needle is vertically inserted into the corresponding depth of the acupoint. After the needle is transported to "get qi", moxibustion will be added at acupoints. The moxibustion distance is about 3cm from the skin, and the local temperature is warm and the patient felt comfortable with the skin. Replace it after burning out. During the acupuncture treatment, in order to avoid burns, it is necessary to strictly control the distance between moxibustion and skin. In the supine position, cardboard should be placed between moxibustion and skin to prevent burns, and ashes should be removed after moxibustion is completely burned. The needle is left for 20 minutes.

Observation - warm acupuncture group

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.

Group Type: EXPERIMENTAL

warm acupunctrue

Intervention Type: DEVICE

The sterile acupuncture needle (0.3mm×40mm) is taken, and the acupuncture needle is vertically inserted into the corresponding depth of the acupoint. After the needle is transported to "get qi", moxibustion will be added at acupoints. The moxibustion distance is about 3cm from the skin, and the local temperature is warm and the patient felt comfortable with the skin. Replace it after burning out. During the acupuncture treatment, in order to avoid burns, it is necessary to strictly control the distance between moxibustion and skin. In the supine position, cardboard should be placed between moxibustion and skin to prevent burns, and ashes should be removed after moxibustion is completely burned. The needle is left for 20 minutes.

Interventions

warm acupunctrue

The sterile acupuncture needle (0.3mm×40mm) is taken, and the acupuncture needle is vertically inserted into the corresponding depth of the acupoint. After the needle is transported to "get qi", moxibustion will be added at acupoints. The moxibustion distance is about 3cm from the skin, and the local temperature is warm and the patient felt comfortable with the skin. Replace it after burning out. During the acupuncture treatment, in order to avoid burns, it is necessary to strictly control the distance between moxibustion and skin. In the supine position, cardboard should be placed between moxibustion and skin to prevent burns, and ashes should be removed after moxibustion is completely burned. The needle is left for 20 minutes.

Intervention Type: DEVICE

Other Intervention Names

warm needling method; needle warming moxibustion; acupuncture with warmed needle

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Juan Jiao

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guang'anmen Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CI2021A015

Identifier Type: -

Identifier Source: org_study_id