PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

Study Overview
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Brief Summary
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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.

Official Title
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Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Cupping therapy
* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with fibromyalgia diagnosed according to criteria formulated by American College Rheumatology 2002; Patients whose scores for pain intensity is more than 30mm; Patients who are 20 to 60 years old; Patients who fully understand the process of this research and who are willing to provide informed consent. Exclusion Criteria: The widespread muscular-skeletal pain is caused by some kind of disease, surgery, or other external interference factors (except fibromyalgia); Patients with mental disorders, or other serious organic diseases, such as organ failure; Patients who take oral anodyne medications or accept other interventions for pain relief during the treatment; Pregnant or lactating women; Patients currently participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cupping therapy (randomized)<br>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. | Other: Cupping therapy<br> <br> |
| Experimental: Cupping therapy (non-randomized)<br>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. | Other: Cupping therapy<br> <br> |
| Active Comparator: Acupuncture (non-randomized)<br>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. | Other: Acupuncture<br> <br> |
| Active Comparator: Acupuncture (randomized)<br>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: Acupuncture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002