The Effects of Energy Healing in Fibromyalgia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender Female
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06552728
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, Irvine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Richard Harris, PhD
Principal Investigator Affiliation UCI SSIHI
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Additional Details

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).

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California at Irvine, Irvine, California

Status

Recruiting

Address

University of California at Irvine

Irvine, California, 92617

Site Contact

Richard Harris, PhD

[email protected]

(949) 824-7000