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

Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome

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 .

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: warm acupunctrue

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: warm needling method; needle warming moxibustion; acupuncture with warmed needle
Experimental: 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.	Device: 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.; Other Names: warm needling method; needle warming moxibustion; acupuncture with warmed needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline	A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.	Baseline, week4, week8, week12, week16
The change of the Visual Analogue Scale (VAS) for pain from baseline.	Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.	Baseline, week4, week8, week12, week16
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.	The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.	Baseline, week4, week8, week12, week16
The change of the Perceived Stress Scale (PSS) from baseline.	The Perceived Stress Scale (PSS) is for measuring the perception of stress and The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity	Baseline, week4, week8, week12, week16
The change of the Hamilton Anxiety Scale（HAMA） from baseline.	he Hamilton Anxiety Scale is used to assess the severity of anxiety symptoms and consists of 14 items, with higher scores indicating greater anxiety	Baseline, week4, week8, week12, week16
The change of the Beck II Depression Inventory (BDI) from baseline.	The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.	Baseline, week4, week8, week12, week16
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.	The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status	Baseline, week4, week8, week12, week16
The change of the Minimum Mental State Examination(MMSE) from baseline.	The Minimum Mental State Examination(MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function	Baseline, week4, week8, week12, week16
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	Baseline, week4, week8, week12, week16
Global Impression of Change (PGIC) questionnaire evaluated at week 16.	A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).	week16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; Fibromyalgia; cold-sensitive; needle warming moxibustion; warm acupunctrue
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Hypersensitivity; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CI2021A015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No