Acupuncture for the Treatment of Rheumatoid Arthritis

NCT00404443 | Completed Phase 2

• 1 other identifier: TCM04001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Acupuncture; Electroacupuncture; Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• The changes in the pain score.

  wk52

Secondary Outcomes (3)

• The ACR core disease measures

  wk52

• DAS 28 score

  wk52

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

  wk52

Study Arms (1)

1

SHAM COMPARATOR

arm 1: placebo needle

Device: Acupuncture

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Institute of Chinese Medicine

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 17980044 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Edmund K Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: December 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

CN (1)