Status:
RECRUITING
The Effects of Core Shamanism in Fibromyalgia
Lead Sponsor:
University of California, Irvine
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
This study includes an 8-week long intervention, with 5 one-on-one treatment sessions with Fibromyalgia (FM) participants and shamanic practitioners (SPs). During each treatment session the FM partici...
Eligibility Criteria
Inclusion
- Inclusion 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.
- Exclusion Criteria:
- 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, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
- 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 inconsistent pain scores as deemed by the principal investigator.
- 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.
- Subjects 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 subject's fibromyalgia; or currently receiving monetary compensation as a result of any of the above.
- Inability or unwillingness of an individual to give written informed consent.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06579261
Start Date
August 1 2024
End Date
May 1 2026
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Susan Samueli Integrative Health Institute
Irvine, California, United States, 92617