The Efficacy of Reiki in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Efficacy of Reiki in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051428
• Other study ID #: R21AT001075-01
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2003
• Last updated: August 16, 2006
• Start date: January 2003
• Est. completion date: February 2005

Study information

• Verified date: August 2006
• 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 investigate the effectiveness of Reiki in the treatment of fibromyalgia (FM), a condition characterized by widespread muscle pain and stiffness, often accompanied by sleep disturbance, headaches, irritable bowel syndrome, and psychological distress. Reiki is a form of energy medicine in which practitioners reportedly access universal life energy to heal patients, either by direct contact at specific hand positions or from a distance.

Description:

Fibromyalgia is one of the most common rheumatologic diagnoses. Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention. A vast body of anecdotal literature as well as two randomized controlled trials suggest that Reiki may be an effective treatment for FM, appearing to relieve pain and improve psychological well being. Reiki appears to have no adverse effects and can eventually be self-administered, making it a low-risk, low-cost, potentially patient-empowering intervention. This study will investigate the efficacy of Reiki in the treatment of FM.

One hundred Reiki-naive FM patients will be recruited from a chronic fatigue referral clinic and will participate in an 8-week trial. Patients will be randomized into one of two Reiki groups (direct-contact and distant Reiki) or one of two control groups (sham and placebo). Patients will receive either Reiki or placebo 16 times during the course of the study. Patients will be assessed at study entry, at Weeks 4 and 8, and 12 weeks post-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria

• Fibromyalgia without concurrent medical conditions associated with chronic pain, such as diabetic neuropathy, systemic lupus erythematosus, or severe degenerative joint disease

• Willing to undergo randomization and attend treatments regularly

• Willing to stay on a stable medical regimen during the entire 8-week trial and use only acetaminophen for breakthrough pain

• Live within a one-hour drive of the study site

Exclusion Criteria

• Received Reiki or any other energy medicine (Therapeutic Touch, Qi Gong, SHEN Therapy, etc.)

• Pregnant

• Pending litigation or disability claim related to FM

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Procedure:
• Reiki (distant and direct-contact)

Locations

Country	Name	City	State
United States	Univ of WA - CFS/FM Research Center	Seattle	Washington

Sponsors (1)

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

Country where clinical trial is conducted

United States,