Acupuncture for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404443
• Other study ID #: TCM04001
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2006
• Last updated: May 6, 2008
• Start date: December 2004
• Est. completion date: January 2006

Study information

• Verified date: May 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Acupuncture
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.

Locations

Country	Name	City	State
China	The Institute of Chinese Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in the pain score.		wk52	Yes
Secondary	The ACR core disease measures		wk52	Yes
Secondary	DAS 28 score		wk52	Yes
Secondary	The number of patients who achieved ACR 20 at week 10.		wk52	Yes