Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

Efficacy of CAM Interventions in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096759
• Other study ID #: R21AT002307-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 15, 2004
• Last updated: March 21, 2013
• Start date: November 2004
• Est. completion date: August 2007

Study information

• Verified date: March 2013
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (RA).

Description:

RA is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. Complementary and alternative medicine (CAM) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. While patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. This study will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of RA.

Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires about their RA symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Active adult onset rheumatoid arthritis

• Stable on disease-modifying antirheumatic drugs (DMARDs) or biologic medications

• Able to walk without use of an assistive device

• Resides in greater Los Angeles area

• Willing and able to comply with study requirements

Exclusion Criteria:

• Uncontrolled or untreated medical conditions

• Frequent or uncontrolled disease flares

• Use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Behavioral:
• Tai Chi Chih

• Relaxation training

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RA-related disability
Primary	Health functioning