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

NCT05228990 | Completed

• 1 other identifier: CI2021A015
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

Fibromyalgia; cold-sensitive; needle warming moxibustion; randomized controlled trial; warm acupunctrue

Outcome Measures

Primary Outcomes (1)

• The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.

  range from 0 to 10 cm with higher score indicating more sensitive to cold.

  Baseline, week4, week8, week12, week16

Secondary Outcomes (10)

• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

  Baseline, week4, week8, week12, week16

• The change of the Visual Analogue Scale (VAS) for pain from baseline.

  Baseline, week4, week8, week12, week16

• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.

  Baseline, week4, week8, week12, week16

• The change of the Perceived Stress Scale (PSS) from baseline.

  Baseline, week4, week8, week12, week16

• The change of the Hamilton Anxiety Scale（HAMA） from baseline.

  Baseline, week4, week8, week12, week16

Study Arms (2)

Warm acupuncture - observation group

EXPERIMENTAL

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.

Device: warm acupunctrue

Observation - warm acupuncture group

EXPERIMENTAL

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.

Device: warm acupunctrue

Interventions

warm acupunctrue 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.

Also known as: warm needling method, needle warming moxibustion, acupuncture with warmed needle

Observation - warm acupuncture group; Warm acupuncture - observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 8, 2022
• Study Start: February 14, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)