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Behavioural Intervention

Core Shamanism for Fibromyalgia

N/A
Recruiting
Led By Richard E Richard, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged over 18 and under 75 years
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
Must not have
Peripheral neuropathy of known cause that interferes with daily activities
History of vascular surgery in lower limbs or current lower limb vascular dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial aims to see if a shamanism intervention can help patients with fibromyalgia by reducing their pain and other symptoms. The researchers also want to see if this intervention affects the heart rate

Who is the study for?
This trial is for individuals with fibromyalgia or myofascial pain syndrome. Participants should be willing to undergo a shamanism intervention and attend most study visits. Specific details on who can join are not provided, but typically there would be criteria based on age, health status, and other factors.
What is being tested?
The trial is testing if core shamanism can help reduce pain and improve heart rate, breathing rate, and brain wave outcomes in patients with fibromyalgia. It will also explore whether these effects lead to better synchronization of physiological responses between practitioners and patients.
What are the potential side effects?
Potential side effects are not explicitly mentioned for the core shamanism intervention; however, participants may experience varied reactions due to the spiritual or emotional nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My average pain level in the past week was 4 or higher on a scale of 10.
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I have been diagnosed with fibromyalgia according to the 2016 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have nerve pain or tingling that affects my daily activities.
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I have had vascular surgery on my legs or currently have leg circulation problems.
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I can take over-the-counter pain meds as needed on the day of my EEG test.
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I have heart problems that are not well-managed.
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I have an autoimmune or inflammatory disease that causes pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
: Attendance Measurement
Secondary study objectives
: Pain Measurement using Brief Pain Index (BPI) which uses a 0-10 numeric rating scale
: Visual Analog Scale (VAS) Scales which uses a 10 cm visual scale.
Other study objectives
Exploratory Outcomes: Breathing Rate measured in breaths per minute
Exploratory Outcomes: Electrocardiogram (ECG) measured in millivolts and seconds or milliseconds (ms)
Exploratory Outcomes: Electroencephalogram (EEG) measured in microvolts

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fibromyalgia participants - Shamanic InterventionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
559 Previous Clinical Trials
1,929,983 Total Patients Enrolled
2 Trials studying Fibromyalgia
70 Patients Enrolled for Fibromyalgia
Richard E Richard, PhDPrincipal InvestigatorUCI SSIHI
~17 spots leftby Mar 2025
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