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RecruitingNCT06552728ClinicalTrials.gov record

The Effects of Energy Healing in Fibromyalgia

Fibromyalgia

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 75 years
Sex eligible
Female
Healthy volunteers
Accepted
Participants
25 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
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

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Neural connectivity

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

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.

Secondary measures

Pain severity

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

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.

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

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

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

University of California at IrvineIrvine, California, United StatesRecruiting

Study team and timeline

Lead sponsor
University of California, Irvine
Study start
Dec 3, 2024 Actual
Primary completion
2026-12 Estimated
Study completion
2027-05 Estimated
First posted
Aug 14, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Richard E Harris, PhDCONTACTrichareh@hs.uci.edu(949) 824-7000
Official study title

The Effects of Energy Healing in Fibromyalgia

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026