Investigating Energy Healing for Fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the clinical effects of Energy Healing (EH) on patients with Fibromyalgia, utilizing functional MRI (fMRI) to assess brain connectivity. It compares active EH to sham EH, focusing on primary outcomes related to brain networks and secondary outcomes concerning pain severity and interference. Additionally, the study explores the relationship between brain connectivity and various symptoms such as mood and fatigue. Participants will undergo multiple sessions of EH or sham EH while their brain activity is monitored.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California at Irvine
  Irvine, California, United States Recruiting

Study contacts

• Principal investigator: Richard Harris, PhD — UCI Ssihi
• Study coordinator: Richard E Harris, PhD
• Email: richareh@hs.uci.edu
• Phone: (949) 824-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.