PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

Beijing University of Chinese Medicine

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Acupuncture; Other: Cupping therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01869712

0100604024

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 4 patient groups

Cupping therapy (randomized)

Experimental group

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.

Treatment:

Other: Cupping therapy

Cupping therapy (non-randomized)

Experimental group

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.

Treatment:

Other: Cupping therapy

Acupuncture (non-randomized)

Active Comparator group

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.

Treatment:

Other: Acupuncture

Acupuncture (randomized)

Active Comparator group

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.

Treatment:

Other: Acupuncture