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New treatment option for Fibromyalgia
Official title The Effects of Core Shamanism in Fibromyalgia
ClinicalTrials.gov ID: NCT06579261
What this study is testing
- What it's testing
- This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism reduces clinical pain and other common symptoms associated with fibromyalgia, and determine if the Shamanism intervention changes heart rate electrocardiogram (ECG), breathing rate, and brain wave electroencephalogram (EEG) outcomes in fibromyalgia patients and shamanic practitioners. The investigators hypothesize that 80% of individuals will complete at least 80% of study visits, clinical pain severity and/or interference will be significantly reduced following the Shamanic intervention, and lung, heart, and/or brain activity will be altered with the Shamanic intervention and also become more synchronized between Shamanic Practitioners (SPs) and patients during the course of treatment.
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
You may be able to join if
- for Fibromyalgia participants:
- Female
- Over 18 and under 75 years of age.
- Fibromyalgia patients and satisfies the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.
- Mean recalled pain over the last seven days (7-day recall) greater than or equal to 4 on a 10 cm Visual Analog Scale (VAS) for pain; 7-day recall.
You likely can't join if
- Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease...
- History of head injury with substantial loss of consciousness
- Peripheral neuropathy of known cause that interferes with activities of daily living.
- Routine daily use of opioid analgesics, marijuana, or history of substance abuse.
- Stimulant medications, such as those used to treat Attention Deficit Disorder (ADD)/Attention-deficit/hyperactivity disorder (ADHD). (e.g...
- Concurrent participation in other therapeutic trials.
See the full eligibility criteria
- for Fibromyalgia participants:
- Female
- Over 18 and under 75 years of age.
- Fibromyalgia patients and satisfies the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.
- Mean recalled pain over the last seven days (7-day recall) greater than or equal to 4 on a 10 cm Visual Analog Scale (VAS) for pain; 7-day recall.
- 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 shamanic treatments 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.
- Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
- History of head injury with substantial loss of consciousness
- Peripheral neuropathy of known cause that interferes with activities of daily living.
- Routine daily use of opioid analgesics, marijuana, or history of substance abuse.
- Stimulant medications, such as those used to treat Attention Deficit Disorder (ADD)/Attention-deficit/hyperactivity disorder (ADHD). (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate...
- Concurrent participation in other therapeutic trials.
- Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG) testing.
- Use of PRN opioid analgesics 48 hours prior to electroencephalogram (EEG) testing.
- Pregnant or nursing. A pregnancy test will be given prior to electroencephalogram (EEG) sessions.
- Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
- Contraindications to EEG methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.
- Any impairment, activity or situation that is in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or...
- Sufficient knowledge of Shamanism techniques that may bias participant outcomes.
- Presence of factors that may preclude the safe use of the Shamanism intervention.
- History vascular surgery in lower limbs or current lower limb vascular dysfunction.
- Presence of uncontrolled cardiovascular disease.
- people with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the...
- Inability or unwillingness of an individual to give written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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. 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.