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Acupuncture for the Treatment of Rheumatoid Arthritis

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Device: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00404443
TCM04001

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 1 patient group

1
Sham Comparator group
Description:
arm 1: placebo needle
Treatment:
Device: Acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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