Clinical trial NCT01869712: PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies
Official title: Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: cupping therapy
acupuncture
partially randomized
patient preference
fibromyalgia
criteria formulated by American College Rheumatology 2002
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patients' compliance
timeFrame: 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
measure: Patients satisfactory for the treatment
timeFrame: The satisfactory for the treatment is investigated at week 5 (as the end of the treatment).
measure: Practitioners' attitude for the research model
timeFrame: Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).
Secondary outcomes:
measure: Adverse events
timeFrame: 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: Patients' expectation for the treatment
timeFrame: Patients' expectation is investigated at week 0
measure: Visual Analogue Scale (VAS) for pain intensity
timeFrame: 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.
Other outcomes:
measure: Widespread Pain Index (WPI）for pain intensity
timeFrame: 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.
measure: Symptom Severity (SS) for pain intensity
timeFrame: 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.
measure: Hamilton Depression Scale (HAMD)
timeFrame: HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.
measure: Quality of life measured by The Medical Outcome Study 36-item short-form health survey (SF36)
timeFrame: SF36 is measured totally 3 times at week 0, week 5 and week 17, respectively.
measure: Fibromyalgia Intensive Questionnaire (FIQ)
timeFrame: FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively.
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine Affiliated Dongfang Hospital
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Huijuan Cao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.