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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
Beijing University of Chinese Medicine Affiliated Dongfang Hospital
Beijing, Beijing Municipality, China
Patients' compliance
Time frame: 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".
Time frame: 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.
Time frame: Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).
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.
Time frame: 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".
Time frame: Patients' expectation is investigated at week 0
Visual Analogue Scale (VAS) for pain intensity
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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.
Time frame: 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.