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PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

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ClinicalTrials.gov Identifier: NCT01869712
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Huijuan Cao, Beijing University of Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Cupping therapy Other: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study
Actual Study Start Date : July 23, 2013
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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



Primary Outcome Measures :
  1. Patients' compliance [ Time Frame: 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 ]
  2. Patients satisfactory for the treatment [ Time Frame: 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".

  3. Practitioners' attitude for the research model [ Time Frame: 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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 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.

  2. Patients' expectation for the treatment [ Time Frame: 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".

  3. Visual Analogue Scale (VAS) for pain intensity [ Time Frame: 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 Outcome Measures:
  1. Widespread Pain Index (WPI)for pain intensity [ Time Frame: 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.

  2. Symptom Severity (SS) for pain intensity [ Time Frame: 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

  3. Hamilton Depression Scale (HAMD) [ Time Frame: HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively. ]
  4. Quality of life measured by The Medical Outcome Study 36-item short-form health survey (SF36) [ Time Frame: SF36 is measured totally 3 times at week 0, week 5 and week 17, respectively. ]
  5. Fibromyalgia Intensive Questionnaire (FIQ) [ Time Frame: FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively. ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869712


Locations
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China, Beijing
Beijing University of Chinese Medicine Affiliated Dongfang Hospital
Beijing, Beijing, China, 100078
Sponsors and Collaborators
Beijing University of Chinese Medicine
Investigators
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Principal Investigator: Huijuan Cao, Ph.D. Beijing University of Chinese Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Huijuan Cao, Research Associate, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01869712    
Other Study ID Numbers: 0100604024
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Keywords provided by Huijuan Cao, Beijing University of Chinese Medicine:
cupping therapy
acupuncture
partially randomized
patient preference
fibromyalgia
criteria formulated by American College Rheumatology 2002
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases