The Efficacy of Reiki in the Treatment of Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Reiki (distant and direct-contact)
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Reiki, Energy Medicine
Eligibility Criteria
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
Sites / Locations
- Univ of WA - CFS/FM Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00051428
First Posted
January 9, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00051428
Brief Title
The Efficacy of Reiki in the Treatment of Fibromyalgia
Official Title
The Efficacy of Reiki in the Treatment of Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Reiki, Energy Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Reiki (distant and direct-contact)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dedra S. Buchwald
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ of WA - CFS/FM Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Reiki in the Treatment of Fibromyalgia
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