RECRUITING

The Effects of Energy Healing in Fibromyalgia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Energy Healing in Fibromyalgia

Quick Facts

Study Start:2024-12-03

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06552728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Richard E Harris, PhD

CONTACT

(949) 824-7000

richareh@hs.uci.edu

Principal Investigator

Richard Harris, PhD

PRINCIPAL_INVESTIGATOR

UCI SSIHI

Study Locations (Sites)

University of California at Irvine

Irvine, California, 92617

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Richard Harris, PhD, PRINCIPAL_INVESTIGATOR, UCI SSIHI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-12-03

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Fibromyalgia