The Effects of Core Shamanism in Fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT06579261
• Lead Sponsor: University of California, Irvine

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 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.

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 participant will listen to classical music first as a control, followed by drumming music (4-7 beats/sec) for 15-30 minutes with the SP and a debrief session. The SP will employ the structure and principles of "Core Shamanism" as developed by Michael Harner. The first and last treatment sessions will include EEG measurements of both the patient and practitioner, while all sessions will have ECG and breathing rate for both patient and practitioner.

Pre screening questionnaires will be administered prior to shamanic treatments to ensure patients and SPs meet study inclusion criteria and give consent to the intervention. Following consent, pre and post treatment questionnaires will be administered to patient and SP participants to capture symptoms of fibromyalgia and treatment related experiences.

1-, 3-, and 6-month followup visits will involve the same questionnaires being administered and recorded to assess durability of treatment response.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-30
• Status Verified: 2024-09
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

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 ADD/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 PRN over the counter (OTC) pain medications (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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Outcomes: Attendance Measurement	Pre screening (2-4 weeks prior to start of treatment visits), Baseline (Pre treatment visit Day 0), Treatment Visits 1-5 (To be done over 8 week long period), Post Treatment Assessment, 1-, 3-, and 6-month follow ups Post-treatment visit 5	To investigate the primary outcome of feasibility, the investigators will record attendance and assess how many Fibromyalgia (FM) patients complete 80% of treatment visits (4 out of 5 sessions). Participants who complete at least 80% of visits will be marked as a completer and those who attend less than 80% of treatment visits will be marked as a "non-completer". The investigators will perform a completer versus non-completer analysis on all participants enrolled.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes: Pain Measurement using Brief Pain Index (BPI) which uses a 0-10 numeric rating scale	Pre screening (2-4 weeks prior to start of treatment visits), Baseline (Pre treatment visit Day 0), Treatment Visits 1-5 (To be done over 8 week long period), Post Treatment Assessment, 1-, 3-, and 6-month follow ups Post-treatment visit 5	Pain and other outcomes will be assessed at the University of California, Irvine by trained clinical research coordinators. The secondary outcomes for the study are pain severity and interference. These outcomes will be assessed with the Brief Pain Inventory (BPI). BPI is measured in the form of a participant self report questionnaire. It will measure where in the body pain is present and its severity as well as how much that pain is impacting daily life.
Secondary outcomes: Visual Analog Scale (VAS) Scales which uses a 10 cm visual scale.	Pre screening (2-4 weeks prior to start of treatment visits), Baseline (Pre treatment visit Day 0), Treatment Visits 1-5 (To be done over 8 week long period), Post Treatment Assessment, 1-, 3-, and 6-month follow ups Post-treatment visit 5	Pain and other outcomes will be assessed at the University of California, Irvine by trained clinical research coordinators. The investigators will have each FM patient complete a 10 cm Visual Analog Scale (VAS) scale with anchors at 0 of "no pain" and 10 as "the worst pain imaginable". A VAS 7 day average recall will be used for inclusion into the study. Patients must score above a 4 on the VAS 7 day recall to be eligible to participate in this study. A daily VAS pain report and present VAS pain report will also be asked during screening, baseline, pre treatment, post treatment assessment visits, and 1-, 3-, and 6-month follow up visits.

Trial Locations

Locations (1)

Susan Samueli Integrative Health Institute; 🇺🇸 Irvine, California, United States