Investigating Energy Healing for Fibromyalgia
The Effects of Energy Healing in Fibromyalgia
This study is testing whether energy healing can help people with fibromyalgia feel better by looking at how it affects their brain activity and pain levels compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06552728 on ClinicalTrials.gov |
What this trial studies
This study examines the clinical effects of Energy Healing (EH) on patients with Fibromyalgia, utilizing functional MRI (fMRI) to assess brain connectivity. It compares active EH to sham EH, focusing on primary outcomes related to brain networks and secondary outcomes concerning pain severity and interference. Additionally, the study explores the relationship between brain connectivity and various symptoms such as mood and fatigue. Participants will undergo multiple sessions of EH or sham EH while their brain activity is monitored.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 who meet the diagnostic criteria for Fibromyalgia and experience significant pain.
Not a fit: Patients who have received Energy Healing in the past six months or have contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel non-pharmacological treatment option for managing Fibromyalgia symptoms.
How similar studies have performed: While the approach of using Energy Healing is relatively novel, similar studies exploring alternative therapies for chronic pain have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Over 18 and under 75 years of age. * Fibromyalgia patients must meet the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM. * Mean recalled pain over the last seven days (7-day recall) between 4-10 cm on Visual - - - - Analog Scale (VAS) for pain with no pain free days in the last 2 months and active pain in resting state lying on back. * No contraindications for MRI, such as metal in the body or electrical devices in the body. * Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study. * Able to travel to the study site to receive MRI, EH, and sham EH sessions up to twice weekly. * Understanding and willing to complete all study procedures. * Capable of giving written informed consent. * Proficient ability to speak, read, and write in english. Exclusion Criteria: * EH within the last 6-months. * Have received past treatment from Charlie Goldsmith or know of him or his work. * Contraindications to MRI and fcMRI methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material, claustrophobia, etc. \[Note: a more formal description of contraindications for MRI is present -in our DSM Plan\]. * Presence of known past procedures, devices in the body, claustrophobia, or other contraindications for MRI * Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain. * Peripheral neuropathy that interferes with activities of daily living. * Routine daily use of narcotic analgesics or history of substance abuse. * Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded. * Concurrent participation in other therapeutic trials. * Pregnant or nursing. * Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation). * Active substance abuse disorder in the past 24 months as determined by subject self-report. * Use of PRN over the counter (OTC) pain medications (NSAIDs, etc.) on day of MRI scan. * Use of PRN narcotic pain medication 48 hours prior to MRI scan. * Current active litigation for FM pain. * Any impairment, activity or situation that in the judgment of the Principal Investigator or other team member that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
Where this trial is running
Irvine, California
- University of California at Irvine — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Richard Harris, PhD — UCI Ssihi
- Study coordinator: Richard E Harris, PhD
- Email: richareh@hs.uci.edu
- Phone: (949) 824-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.