PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-23

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cupping therapy

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Cupping therapy

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Interventions

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Cupping therapy

Intervention Type OTHER

Acupuncture

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No