Core shamanism for people living with fibromyalgia pain
Tests core shamanism for pain and other symptoms in adults with fibromyalgia.
Key facts
- Who runs it
- University of California, Irvine
- Where
- Irvine, United StatesSee the site
- Trial code
- Registry title
- The Effects of Core Shamanism in Fibromyalgia
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 1 Aug 2024
- Expected to end
- Dec 2026
- Type of study
- Interventional
- Treatments tested
- Core Shamanism
- Record updated
- 23 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with fibromyalgia who have ongoing pain. They will receive a Core Shamanism treatment at the study site.
- Age
- Over 18 and under 75 years of age.
- Sex
- Women only.
- Disease stage
- Fibromyalgia that meets the 2016 Fibromyalgia Diagnostic Criteria. Average pain over the last 7 days of 4 or more on a 10 cm (3.9 in) pain scale.
- Earlier treatment
- People must agree not to start new medicines or treatments for fibromyalgia during the study. Routine daily use of opioid painkillers, marijuana or stimulant medicines is not allowed.
Main reasons for not taking part
- Another autoimmune or inflammatory disease that causes pain, such as rheumatoid arthritis or lupus.
- Head injury with substantial loss of consciousness, or past substance abuse.
- Pregnant or breastfeeding.
- Severe mental illness, or metal in the body that prevents brain wave (EEG) testing.
- Uncontrolled heart or blood vessel disease, or compensation or legal claims related to fibromyalgia.
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain
- 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
- Contraindications to EEG methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material
- History vascular surgery in lower limbs or current lower limb vascular dysfunction
- 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
- History of head injury with substantial loss of consciousness
- 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
- Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years)
- 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
- Presence of uncontrolled cardiovascular disease
- Peripheral neuropathy of known cause that interferes with activities of daily living
- Sufficient knowledge of Shamanism techniques that may bias participant outcomes
- Presence of factors that may preclude the safe use of the Shamanism intervention
- Inability or unwillingness of an individual to give written informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Susan Samueli Integrative Health InstituteIrvine, United StatesContact: Huiyi Bao, B.S., B.A.Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Fibromyalgia participants - Shamanic InterventionTreatment being tested
Treatment: Core Shamanism
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effects of Core Shamanism in Fibromyalgia
- Plain-language title
- Core shamanism for people living with fibromyalgia painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06579261, who can take part
- Record updated
- 23 June 2026