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To assess the application of partially randomized patient preference (PRPP) trial model which concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cupping therapy (randomized) | Experimental | Use retained cupping as the main cupping method, supplemented with flash cupping and/or moving cupping. First use empty cupping, which means the cups are removed after suction without delay, then practitioners should control the suction by gently moving the cup toward direction of DU and/or BL, repeat this moving for several times, finally cupping practitioners utilize the flaming heating power to achieve suction (minus pressure) inside the cups to make them apply on the desired part of the body. Cups should retain for 10 minutes daily, patients accept the treatment three times weekly for totally 15 times. |
|
| Cupping therapy (non-randomized) | Experimental | Use retained cupping as the main cupping method, supplemented with flash cupping and/or moving cupping. First use empty cupping, which means the cups are removed after suction without delay, then practitioners should control the suction by gently moving the cup toward direction of DU and/or BL, repeat this moving for several times, finally cupping practitioners utilize the flaming heating power to achieve suction (minus pressure) inside the cups to make them apply on the desired part of the body. Cups should retain for 10 minutes daily, patients accept the treatment three times weekly for totally 15 times. |
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| Acupuncture (non-randomized) | Active Comparator | Sterilize the selected points with alcohol, and then select the specific size of needles to do the acupuncture. Do the manual stimulation for seconds after needles' insertion, including twist, pull up and deeper insert. Needles should be withdrawn after 30 minutes. Patients accept the treatment three times weekly for totally 15 times. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cupping therapy | Other |
| ||
| Acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' compliance | Record the number of drop out or lost during the 5 weeks' treatment and 3 months' follow up duration (for an expected totally 17 weeks) and note the reason for missing data | |
| Patients satisfactory for the treatment | Satisfactory for the treatment is measured by a seven-score scale, with 1 for "very satisfied" and 7 for "very unsatisfied". | The satisfactory for the treatment is investigated at week 5 (as the end of the treatment). |
| Practitioners' attitude for the research model | Individual interview or the focus group interview will be applied after the treatment, all the practitioners in the study (including acupuncturists and cupping therapy practitioners) will be interviewed to know their attitude for conducting the partially randomized patient preference trial model and their thoughts of this model compare to general randomized controlled trial. | Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Researchers should note any minor or serious adverse event occurs during treatment and follow up duration, including cases and symptoms of patients with adverse events. | Adverse events will be observed for the duration of 5 weeks' treatment and 3 months' follow-up, with an expected average of totally 17 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Widespread Pain Index (WPI）for pain intensity | WPI is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia. | WPI should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huijuan Cao, Ph.D. | Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University of Chinese Medicine Affiliated Dongfang Hospital | Beijing | Beijing Municipality | 100078 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21701180 | Background | Cao H, Hu H, Colagiuri B, Liu J. Medicinal cupping therapy in 30 patients with fibromyalgia: a case series observation. Forsch Komplementmed. 2011;18(3):122-6. doi: 10.1159/000329329. Epub 2011 May 24. | |
| 20423209 | Background | Cao H, Liu J, Lewith GT. Traditional Chinese Medicine for treatment of fibromyalgia: a systematic review of randomized controlled trials. J Altern Complement Med. 2010 Apr;16(4):397-409. doi: 10.1089/acm.2009.0599. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000079742 | Cupping Therapy |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Acupuncture (randomized) | Active Comparator | Sterilize the selected points with alcohol, and then select the specific size of needles to do the acupuncture. Do the manual stimulation for seconds after needles' insertion, including twist, pull up and deeper insert. Needles should be withdrawn after 30 minutes. |
|
| Other |
|
| Patients' expectation for the treatment |
Patients' expectation is measured by a four-score scale, with 1 for "symptoms are totally disappear" and 4 for "no change for symptoms". |
| Patients' expectation is investigated at week 0 |
| Visual Analogue Scale (VAS) for pain intensity | The length of scale of VAS is 100mm, 0 is representing for no pain, and 100 is representing unbearable pain which may affect appetite and quality of sleep. Researchers should show the scale to patients, and note the scores of pain degree given by patients according to the scale. | VAS should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively. |
| Symptom Severity (SS) for pain intensity |
SS is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia |
| SS should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively. |
| Hamilton Depression Scale (HAMD) | HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively. |
| Quality of life measured by The Medical Outcome Study 36-item short-form health survey (SF36) | SF36 is measured totally 3 times at week 0, week 5 and week 17, respectively. |
| Fibromyalgia Intensive Questionnaire (FIQ) | FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively. |
| 25012121 | Derived | Cao HJ, Liu JP, Hu H, Wang NS. Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial. Trials. 2014 Jul 10;15:280. doi: 10.1186/1745-6215-15-280. |
| D009422 |
| Nervous System Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |