The Effects of Energy Healing in Fibromyalgia

NCT ID: NCT06552728

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2027-05-31

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.

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fibromyalgia participants - Energy Healing Intervention

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

Group Type: EXPERIMENTAL

Energy Healing

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Richard Edmund Harris

Samueli Endowed Chair and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

UCI SSIHI

Locations

University of California at Irvine

Irvine, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard E Harris, PhD

Role: CONTACT

richareh@hs.uci.edu

(949) 824-7000

Facility Contacts

Richard Harris, PhD

Role: primary

richareh@hs.uci.edu

(949) 824-7000

Other Identifiers

5179

Identifier Type: -

Identifier Source: org_study_id