PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869712
• Other study ID #: 0100604024
• Status: Completed
• Phase: N/A
• Start date: July 23, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2019
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 31, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Cupping therapy

• Acupuncture

Locations

Country	Name	City	State
China	Beijing University of Chinese Medicine Affiliated Dongfang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Hamilton Depression Scale (HAMD)		HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.
Other	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.
Other	Fibromyalgia Intensive Questionnaire (FIQ)		FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively.
Primary	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
Primary	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).
Primary	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	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.
Secondary	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
Secondary	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.