Exploring the effects of Core Shamanism on fibromyalgia symptoms
The Effects of Core Shamanism in Fibromyalgia
NA · University of California, Irvine · NCT06579261
This study is testing whether a special shamanic treatment can help people with fibromyalgia feel less pain and improve their symptoms over eight weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06579261 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and efficacy of a Core Shamanism intervention for patients suffering from fibromyalgia. Over an 8-week period, participants will engage in five one-on-one treatment sessions with shamanic practitioners, alternating between classical music and drumming music to assess changes in clinical pain and other fibromyalgia symptoms. The study will also measure physiological changes in heart rate, breathing rate, and brain activity through ECG and EEG assessments. Participants will complete pre and post-treatment questionnaires, with follow-up assessments at 1, 3, and 6 months to evaluate the durability of treatment effects.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 who meet the diagnostic criteria for fibromyalgia and experience moderate to severe pain.
Not a fit: Patients with concurrent autoimmune or inflammatory diseases, or those with a history of significant head injury, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel approach to reducing pain and improving quality of life for fibromyalgia patients.
How similar studies have performed: While the approach of using shamanism is relatively novel, other studies exploring alternative therapies for fibromyalgia have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Irvine, California
- Susan Samueli Integrative Health Institute — Irvine, California, United States (RECRUITING)
Study contacts
- Principal investigator: Richard E Richard, PhD — UCI SSIHI
- Study coordinator: University of California, Irvine Susan Samueli Integrative Health Institute
- Email: ssihi@hs.uci.edu
- Phone: 949-824-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, fibromyalgia chronic pain