Acupuncture for the Treatment of Rheumatoid Arthritis

Study Overview
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Brief Summary
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To study the efficacy of acupuncture used as an adjunct measure for patients with refractory RA

Detailed Description
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The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional Chinese acupuncture and sham acupuncture in patients with refractory RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10.

Official Title
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Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilled The American College of Rheumatology (ACR)[10] criteria of RA Active disease affecting the hands and wrists defined as having at least 4 tender joints and 2 swollen joints Early morning stiffness of greater than 45 minutes ESR > 28 mmHg or CRP > 10 Patients taking disease modifying anti-rheumatic drugs (DMARDs) were eligible if they were on a stable dose for at least 3 months before screening. Patients on stable doses of one non-steroidal anti-inflammatory drug (NSAID) or up to 10 mg daily prednisone were also included. Exclusion Criteria: Under the age of 18 years Pregnancy Previously had acupuncture Localized skin infections Anticoagulated Bleeding diathesis Intra-articular corticosteroid within 4 weeks preceding the study Any severe chronic or uncontrolled co-morbid disease Fear of needles

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1<br>arm 1: placebo needle | Device: Acupuncture<br>* Placebo-needles 17 will be used for those randomized to receive sham-acupuncture, which will be connected to the electrical current generator for the same duration and at the same acupuncture points without any current passing through, and intermittent non-specific manual twirling will also be applied. Patients are discouraged to communicate with each other before and after the treatment sessions to minimize bias.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in the pain score. |  | wk52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ACR core disease measures |  | wk52 | 
| DAS 28 score |  | wk52 | 
| The number of patients who achieved ACR 20 at week 10. |  | wk52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Electroacupuncture, Rheumatoid arthritis