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New treatment option for Fibromyalgia
Official title The Effects of Energy Healing in Fibromyalgia
ClinicalTrials.gov ID: NCT06552728
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- No contraindications for MRI, such as metal in the body or electrical devices in the body.
You likely can't join if
- 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...
- 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...
- Peripheral neuropathy that interferes with activities of daily living.
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.