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

Key facts

Who runs it
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
38 people enrolled
Started
14 Feb 2022
Ended
31 Dec 2023
Type of study
Interventional, 2 groups
Treatments tested
  • warm acupunctrue
Record updated
21 October 2024

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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 .

The 2 groups in the trial

  • Warm acupuncture - observation groupTreatment being tested

    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: warm acupunctrue

  • Observation - warm acupuncture groupTreatment being tested

    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: warm acupunctrue

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
Record updated
21 October 2024