Acupuncture for the Treatment of Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: Acupuncture

• Registration Number: NCT00404443
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Acupuncture	arm 1: placebo needle

Primary Outcome Measures

Name	Time	Method
The changes in the pain score.	wk52

Secondary Outcome Measures

Name	Time	Method
The ACR core disease measures	wk52
DAS 28 score	wk52
The number of patients who achieved ACR 20 at week 10.	wk52

Trial Locations

Locations (1)

The Institute of Chinese Medicine; 🇨🇳 Hong Kong, China