The Effects of Energy Healing in Fibromyalgia

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Energy Healing

Detailed Description

The primary objective is to investigate the effects of energy healing as compared to sham EH on brain connectivity of the insula/salience network, sensory motor network, and default mode network as primary outcomes using fcMRI.

The secondary objective is to evaluate the effectiveness of EH in reducing clinical pain severity and interference (secondary outcomes) and their relationship to brain connectivity (secondary outcomes) as compared to placebo/sham EH.

The exploratory objective is to understand the effects of EH versus sham EH on brain functional response to visual stimuli, insular glutamate, heart rate variability, mood, sleep, and fatigue symptoms in fibromyalgia patients (all exploratory outcomes).

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard E Harris, PhD; Phone Number: (949) 824-7000; Email: richareh@hs.uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • Recruiting
      • University of California at Irvine
      • Contact: Richard Harris, PhD; Phone Number: (949) 824-7000; Email: richareh@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fibromyalgia participants - Energy Healing Intervention; Female Fibromyalgia patients ages 18-75 who meet inclusion/exclusion criteria as stated in the IRB approved study protocol.

Other: Energy Healing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	changes in pain severity and interference and their relationships to brain connectivity. We will determine if EH is effective in reducing clinical pain severity and interference as compared to placebo/sham EH and assess changes in their relationships before and after EH/sham EH to changes in brain connectivity.	Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment
Effects of Energy Healing vs sham Energy Healing on brain functional response	As exploratory outcomes, we will also explore the effects of EH vs sham EH on brain functional response to visual stimuli, insular Glx, heart rate variability, mood, sleep, and fatigue symptoms in FM patients.	Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Richard Harris, PhD, UCI SSIHI

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: 5179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No