Text Size

Acupuncture for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00404443
First received: November 27, 2006
Last updated: May 6, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Device: Acupuncture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The changes in the pain score. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The ACR core disease measures [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]
  • DAS 28 score [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]
  • The number of patients who achieved ACR 20 at week 10. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: December 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
arm 1: placebo needle
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404443

Locations
China
The Institute of Chinese Medicine
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lai-Shan Tam, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00404443     History of Changes
Other Study ID Numbers: TCM04001
Study First Received: November 27, 2006
Last Updated: May 6, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Acupuncture
Electroacupuncture
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013