The Efficacy of Reiki in the Treatment of Fibromyalgia - Tabular View

Tracking Information

First Received Date ^ICMJE

January 9, 2003

Last Updated Date

August 16, 2006

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00051428 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Efficacy of Reiki in the Treatment of Fibromyalgia

Official Title ^ICMJE

The Efficacy of Reiki in the Treatment of Fibromyalgia

Brief 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.

Detailed 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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Procedure: Reiki (distant and direct-contact)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00051428

Responsible Party

Study ID Numbers ^ICMJE

R21 AT001075-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dedra S. Buchwald

University of Washington

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP