Skip to main content
OpenTrials
Completed

NCT Number: NCT00404443

Acupuncture for the Treatment of Rheumatoid Arthritis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Institute of Chinese Medicine

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

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.

Primary outcomes

  1. The changes in the pain score.

    Time frame: wk52

Secondary outcomes

  1. The ACR core disease measures

    Time frame: wk52

  2. DAS 28 score

    Time frame: wk52

  3. The number of patients who achieved ACR 20 at week 10.

    Time frame: wk52

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 28, 2006
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.