The Effects of Energy Healing in Fibromyalgia

NCT06552728 | Recruiting DMC

• 1 other identifier: 5179
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to study the clinical effects of Energy Healing using fMRI and determine its application to Fibromyalgia patients. We also want to find out how active Energy Healing compares to sham Energy Healing in terms of brain connectivity and pain interference scores.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Neural connectivity

  change in brain connectivity of the insula/salience network (SLN), sensory motor network (SMN), and default mode network (DMN) resulting from energy healing (EH) as compared to sham EH.

  Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment

Secondary Outcomes (2)

• Pain severity

  Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment

• Effects of Energy Healing vs sham Energy Healing on brain functional response

  Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment

Study Arms (1)

Fibromyalgia participants - Energy Healing Intervention

EXPERIMENTAL

Female Fibromyalgia patients ages 18-75 who meet inclusion/exclusion criteria as stated in the IRB approved study protocol.

Other: Energy Healing

Interventions

Energy Healing OTHER

EH derives from the theory that by using the body's biological energy, there can be a therapeutic effect that guides the patient towards a homeostatic state. Preliminary data in chronic pain patients, suggests that EH, delivered by an experienced practitioner, is able to reduce self-reported pain symptoms within minutes. Effects lasting for weeks to months have also been anecdotally reported. For patients with pain, this can result in a reduction of symptoms. Participants will also be presented with sham EH as a control.

Fibromyalgia participants - Energy Healing Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California at Irvine

Irvine, California, 92617, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Richard Harris, PhD

  UCI SSIHI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard E Harris, PhD

CONTACT

(949) 824-7000; richareh@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samueli Endowed Chair and Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-09

Locations

US (1)