Fibromyalgia
Conditions
Keywords
cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002
Brief summary
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.
Interventions
OTHERCupping therapy
OTHERAcupuncture
Sponsors
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Practitioners' attitude for the research model | Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment). | 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. |
| Patients satisfactory for the treatment | The satisfactory for the treatment is investigated at week 5 (as the end of the treatment). | Satisfactory for the treatment is measured by a seven-score scale, with 1 for very satisfied and 7 for very unsatisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Patients' expectation for the treatment | Patients' expectation is investigated at week 0 | Patients' expectation is measured by a four-score scale, with 1 for symptoms are totally disappear and 4 for no change for symptoms. |
| Visual Analogue Scale (VAS) for pain intensity | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAMD) | HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively. | — |
| Symptom Severity (SS) for pain intensity | 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. | SS is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia |
| 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. | — |
| Widespread Pain Index (WPI）for pain intensity | 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. | WPI is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia. |
Countries
China
Outcome results
None listed