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PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cupping therapy
Acupuncture
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing University of Chinese Medicine Affiliated Dongfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Cupping therapy (randomized)

Cupping therapy (non-randomized)

Acupuncture (non-randomized)

Acupuncture (randomized)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Patients' compliance
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".
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.

Secondary Outcome Measures

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.
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".
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.

Full Information

First Posted
May 22, 2013
Last Updated
July 9, 2019
Sponsor
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01869712
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cupping therapy (randomized)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cupping therapy (non-randomized)
Arm Type
Experimental
Arm Description
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.
Arm Title
Acupuncture (non-randomized)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acupuncture (randomized)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cupping therapy
Intervention Type
Other
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
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
Title
Patients satisfactory for the treatment
Description
Satisfactory for the treatment is measured by a seven-score scale, with 1 for "very satisfied" and 7 for "very unsatisfied".
Time Frame
The satisfactory for the treatment is investigated at week 5 (as the end of the treatment).
Title
Practitioners' attitude for the research model
Description
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.
Time Frame
Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
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.
Title
Patients' expectation for the treatment
Description
Patients' expectation is measured by a four-score scale, with 1 for "symptoms are totally disappear" and 4 for "no change for symptoms".
Time Frame
Patients' expectation is investigated at week 0
Title
Visual Analogue Scale (VAS) for pain intensity
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Widespread Pain Index (WPI）for pain intensity
Description
WPI is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia.
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.
Title
Symptom Severity (SS) for pain intensity
Description
SS is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia
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.
Title
Hamilton Depression Scale (HAMD)
Time Frame
HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.
Title
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.
Title
Fibromyalgia Intensive Questionnaire (FIQ)
Time Frame
FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijuan Cao, Ph.D.
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing University of Chinese Medicine Affiliated Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21701180
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.
Results Reference
background
PubMed Identifier
20423209
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.
Results Reference
background
PubMed Identifier
25012121
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.
Results Reference
derived

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PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

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