Acupuncture for the Treatment of Rheumatoid Arthritis - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00404443

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Rheumatoid Arthritis

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
1: Sham Comparator 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.

Arms

Assigned Interventions

1: Sham Comparator

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 National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Chinese University of Hong Kong:

Acupuncture
Electroacupuncture
Rheumatoid arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 03, 2009