PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

NCT01869712 | Completed DMC

• 1 other identifier: 0100604024
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

cupping therapy; acupuncture; partially randomized; patient preference; fibromyalgia; criteria formulated by American College Rheumatology 2002

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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 investigated at week 0

• 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.

Other Outcomes (5)

• 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.

• 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.

• Hamilton Depression Scale (HAMD)

  HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.

Study Arms (4)

Cupping therapy (randomized)

EXPERIMENTAL

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

Cupping therapy (non-randomized)

EXPERIMENTAL

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

Acupuncture (non-randomized)

ACTIVE COMPARATOR

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

Acupuncture (randomized)

ACTIVE COMPARATOR

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

Interventions

Cupping therapy OTHER

Cupping therapy (non-randomized); Cupping therapy (randomized)

Acupuncture OTHER

Acupuncture (non-randomized); Acupuncture (randomized)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Beijing University of Chinese Medicine Affiliated Dongfang Hospital

Beijing, Beijing Municipality, 100078, China

Location

Related Publications (3)

• 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.

  PMID: 21701180 BACKGROUND

• 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.

  PMID: 20423209 BACKGROUND

• 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.

  PMID: 25012121 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Patient Preference

Interventions

Cupping Therapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Huijuan Cao, Ph.D.

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 5, 2013
• Study Start: July 23, 2013
• Primary Completion: September 15, 2017
• Study Completion: December 31, 2017
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

CN (1)