Clinical trial NCT06579261: The Effects of Core Shamanism in Fibromyalgia
Official title: The Effects of Core Shamanism in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia chronic pain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Primary Outcomes: Attendance Measurement
timeFrame: 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:
measure: Secondary Outcomes: Pain Measurement using Brief Pain Index (BPI) which uses a 0-10 numeric rating scale
timeFrame: 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
measure: Secondary outcomes: Visual Analog Scale (VAS) Scales which uses a 10 cm visual scale.
timeFrame: 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:
measure: Exploratory Outcomes: Electrocardiogram (ECG) measured in millivolts and seconds or milliseconds (ms)
timeFrame: Treatment Visits 1-5 (To be done over 8 week long period)
measure: Exploratory Outcomes: Electroencephalogram (EEG) measured in microvolts
timeFrame: Treatment Visits 1-5 (To be done over 8 week long period)
measure: Exploratory Outcomes: Breathing Rate measured in breaths per minute
timeFrame: Treatment Visits 1-5 (To be done over 8 week long period)
Locations:
city: Irvine
country: United States
facility: Susan Samueli Integrative Health Institute
state: California
Study officials:
affiliation: UCI SSIHI
name: Richard E Richard, PhD
role: PRINCIPAL_INVESTIGATOR
References: