Exploring the effects of Core Shamanism on fibromyalgia symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.