The Effects of Core Shamanism in Fibromyalgia

NCT06579261 | Recruiting DMC

• 1 other identifier: 3326
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia chronic pain

Outcome Measures

Primary Outcomes (1)

• Primary Outcomes: Attendance Measurement

  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.

  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

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (3)

• Exploratory Outcomes: Electrocardiogram (ECG) measured in millivolts and seconds or milliseconds (ms)

  Treatment Visits 1-5 (To be done over 8 week long period)

• Exploratory Outcomes: Electroencephalogram (EEG) measured in microvolts

  Treatment Visits 1-5 (To be done over 8 week long period)

• Exploratory Outcomes: Breathing Rate measured in breaths per minute

  Treatment Visits 1-5 (To be done over 8 week long period)

Study Arms (1)

Fibromyalgia participants - Shamanic Intervention

EXPERIMENTAL

Other: Core Shamanism

Interventions

Core Shamanism OTHER

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.

Fibromyalgia participants - Shamanic Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study will only include women as most individuals with Fibromyalgia (FM) are female. Studying males is not optimal as a study including males would not have the required power with a large enough sample size. There are not enough males to be recruited in the study given the limited resources. This study will be powered well with a female population. Shamanic Practitioners (SPs) can be either male or female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Susan Samueli Integrative Health Institute

Irvine, California, 92617, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Richard E Richard, PhD

  UCI SSIHI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

University of California, Irvine Susan Samueli Integrative Health Institute

CONTACT

949-824-7000; ssihi@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samueli Endowed Chair and Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 30, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-10

Locations

US (1)