PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

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

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 Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Acupuncture; Other: Cupping therapy

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Beijing University of Chinese Medicine Affiliated Dongfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cupping therapy (randomized); 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
Experimental: Cupping therapy (non-randomized); 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
Active Comparator: Acupuncture (non-randomized); 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
Active Comparator: Acupuncture (randomized); 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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Hamilton Depression Scale (HAMD)		HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.
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.

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Huijuan Cao, Ph.D., Beijing University of Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2013
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: fibromyalgia; acupuncture; patient preference; cupping therapy; partially randomized; criteria formulated by American College Rheumatology 2002
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 0100604024