The Effects of Core Shamanism in Fibromyalgia
University of California, Irvine
25 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria9
- 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 Criteria18
- 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.
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Interventions
Each Shamanic intervention session, led by the shamanic practitioner, will include classical music as a control, followed by repetitive drumming and/or rattling music which the participant and shamanic practitioner will listen to for 15-30 mins. Following listening to drumming, the patient will then talk with the shamanic practitioner to debrief the experience of each session. Participants will also listen to classical music as a control stimulus.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06579261