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Acupuncture for the Treatment of Rheumatoid Arthritis

NCT ID: NCT00404443

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Acupuncture Electroacupuncture Rheumatoid arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

arm 1: placebo needle

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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The Chinese University of Hong Kong

Principal Investigators

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Edmund K Li, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Institute of Chinese Medicine

Hong Kong, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 17980044 (View on PubMed)

Other Identifiers

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TCM04001

Identifier Type: -

Identifier Source: org_study_id