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Acupuncture for the Treatment of Rheumatoid Arthritis
This study has been completed.
Study NCT00404443   Information provided by Chinese University of Hong Kong
First Received: November 27, 2006   Last Updated: May 6, 2008   History of Changes

November 27, 2006
May 6, 2008
December 2004
January 2006   (final data collection date for primary outcome measure)
The changes in the pain score. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]
The changes in the pain score.
Complete list of historical versions of study NCT00404443 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The ACR core disease measures
  • DAS 28 score
  • The number of patients who achieved ACR 20 at week 10.
 
Acupuncture for the Treatment of Rheumatoid Arthritis
Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study

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

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Rheumatoid Arthritis
Device: Acupuncture
Sham Comparator: arm 1: placebo needle
Tam LS, Leung PC, Li TK, Zhang L, Li EK. Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study. BMC Complement Altern Med. 2007 Nov 3;7:35.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
36
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00404443
Lai-Shan Tam, The Chinese University of Hong Kong
TCM04001
Chinese University of Hong Kong
 
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
Chinese University of Hong Kong
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP