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Clinical Trials/NCT00404443
NCT00404443CompletedPhase 2

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

Chinese University of Hong Kong1 site in 1 country36 target enrollmentStarted: December 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
The changes in the pain score.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The changes in the pain score.

Time Frame: wk52

Secondary Outcomes

  • The ACR core disease measures(wk52)
  • DAS 28 score(wk52)
  • The number of patients who achieved ACR 20 at week 10.(wk52)

Investigators

Sponsor Class
Other

Study Sites (1)

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