Back to resultsAcupuncture for the Treatment of Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Acupuncture, Electroacupuncture, Rheumatoid arthritis
Eligibility 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
Sites / Locations
- The Institute of Chinese Medicine
Arms of the Study
Arm 1
Arm Type
Sham Comparator
Arm Label
1
Arm Description
arm 1: placebo needle
Outcomes
Primary Outcome Measures
The changes in the pain score.
Secondary Outcome Measures
The ACR core disease measures
DAS 28 score
The number of patients who achieved ACR 20 at week 10.
Full Information
NCT ID
NCT00404443
First Posted
November 27, 2006
Last Updated
May 6, 2008
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00404443
Brief Title
Acupuncture for the Treatment of Rheumatoid Arthritis
Official Title
Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Acupuncture, Electroacupuncture, Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
arm 1: placebo needle
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The changes in the pain score.
Time Frame
wk52
Secondary Outcome Measure Information:
Title
The ACR core disease measures
Time Frame
wk52
Title
DAS 28 score
Time Frame
wk52
Title
The number of patients who achieved ACR 20 at week 10.
Time Frame
wk52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund K Li, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute of Chinese Medicine
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17980044
Citation
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. doi: 10.1186/1472-6882-7-35.
Results Reference
derived
Learn more about this trial
Acupuncture for the Treatment of Rheumatoid Arthritis
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