FibromyalgiaNCT01869712
PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies
A study testing Cupping therapy and Acupuncture in people with Fibromyalgia, run by Beijing University of Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cupping therapy and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing University of Chinese Medicine Affiliated Dongfang Hospital
Beijing, Beijing Municipality, 100078
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Cupping therapy, Acupuncture
- Keywords
- cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002
- Medical subject headings
- Fibromyalgia, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupping therapyOther
AcupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' compliance
Measured: 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".
Measured: 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.
Measured: Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).
Secondary outcomes (3)
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.
Measured: 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".
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study start23 Jul 2013
- Primary completion15 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijuan Cao, Beijing University of Chinese Medicine
- Investigators
- Huijuan Cao, Ph.D., Principal investigator, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869712
- Sponsor's protocol ID
- 0100604024
- Status last verified
- Jul 2019
- First submitted
- 22 May 2013
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21701180Cao 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.
PubMed 20423209Cao 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.
PubMed 25012121
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT01869712
- Acronym / sponsor ID
- 0100604024
- Conditions
- Fibromyalgia
- Keywords
- cupping therapy, acupuncture, partially randomized, patient preference, fibromyalgia, criteria formulated by American College Rheumatology 2002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cupping therapy (randomized) | Experimental | Other: Cupping therapyUse 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. |
| Cupping therapy (non-randomized) | Experimental | Other: Cupping therapyUse 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. |
| Acupuncture (non-randomized) | Active comparator | Other: AcupunctureSterilize 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. |
| Acupuncture (randomized) | Active comparator | Other: AcupunctureSterilize 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cupping therapy | Other | Cupping therapy (non-randomized), Cupping therapy (randomized) |
| Acupuncture | Other | Acupuncture (non-randomized), Acupuncture (randomized) |
Primary outcome
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
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".
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.
3 secondary outcomes
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.
Patients' expectation for the treatment
Time frame: Patients' expectation is investigated at week 0
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Background: PubMed 21701180Cao 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.
- Background: PubMed 20423209Cao 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.
- Derived from this study: PubMed 25012121Cao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huijuan Cao, Ph.D. principal investigator
Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cupping therapy and Acupuncture in people with Fibromyalgia, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.