Fibromyalgia
Conditions
Keywords
Fibromyalgia, cold-sensitive, needle warming moxibustion, randomized controlled trial, warm acupunctrue
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 .
Interventions
DEVICEwarm 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline. | Baseline, week4, week8, week12, week16 | range from 0 to 10 cm with higher score indicating more sensitive to cold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of the Visual Analogue Scale (VAS) for pain from baseline. | Baseline, week4, week8, week12, week16 | Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe. |
| The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. | 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. |
| The change of the Perceived Stress Scale (PSS) from baseline. | 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 |
| The change of the Hamilton Anxiety Scale（HAMA） from baseline. | 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 |
| The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline | 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. |
| The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. | 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 |
| The change of the Minimum Mental State Examination(MMSE) from baseline. | Baseline, week4, week8, week12, week16 | The Minimum Mental State Examination(MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function |
| The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline. | 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. |
| Global Impression of Change (PGIC) questionnaire evaluated at week 16. | 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). |
| The change of the Beck II Depression Inventory (BDI) from baseline. | 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. |
Countries
China
Outcome results
None listed