Clinical trial NCT05228990: Pilot Study of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
Official title: Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
cold-sensitive
needle warming moxibustion
randomized controlled trial
warm acupunctrue
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.
timeFrame: Baseline, week4, week8, week12, week16
Secondary outcomes:
measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Visual Analogue Scale (VAS) for pain from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Perceived Stress Scale (PSS) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Hamilton Anxiety Scale（HAMA） from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Beck II Depression Inventory (BDI) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Minimum Mental State Examination(MMSE) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
timeFrame: Baseline, week4, week8, week12, week16
measure: Global Impression of Change (PGIC) questionnaire evaluated at week 16.
timeFrame: week16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References: