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NCT Number: NCT05228990

Pilot Study 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 .

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: warm needling method, needle warming moxibustion, acupuncture with warmed needle

Primary outcomes

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

    Time frame: Baseline, week4, week8, week12, week16

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

Secondary outcomes

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

    Time frame: Baseline, week4, week8, week12, week16

    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.

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

    Time frame: Baseline, week4, week8, week12, week16

    Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.

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

    Time frame: Baseline, week4, week8, week12, week16

    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.

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

    Time frame: Baseline, week4, week8, week12, week16

    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

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

    Time frame: Baseline, week4, week8, week12, week16

    he Hamilton Anxiety Scale is used to assess the severity of anxiety symptoms and consists of 14 items, with higher scores indicating greater anxiety

  6. The change of the Beck II Depression Inventory (BDI) from baseline.

    Time frame: Baseline, week4, week8, week12, week16

    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.

  7. The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.

    Time frame: Baseline, week4, week8, week12, week16

    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

  8. The change of the Minimum Mental State Examination(MMSE) from baseline.

    Time frame: Baseline, week4, week8, week12, week16

    The Minimum Mental State Examination(MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function

  9. The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.

    Time frame: Baseline, week4, week8, week12, week16

    Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.

  10. Global Impression of Change (PGIC) questionnaire evaluated at week 16.

    Time frame: week16

    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).

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2022
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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