The Effects of Core Shamanism in Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Core Shamanism
Other interventionEach 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Fibromyalgia participants - Shamanic InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
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 5Secondary outcomes
1
Secondary Outcomes: Pain Measurement using Brief Pain Index (BPI) which uses a 0-10 numeric rating scale
Pain and other outcomes will be assessed at the University of California, Irvine by trained clinical research coordinators. The secondary outcomes for the study are pain severity and interference. These outcomes will be assessed with the Brief Pain Inventory (BPI). BPI is measured in the form of a participant self report questionnaire. It will measure where in the body pain is present and its severity as well as how much that pain is impacting daily life.
Time frame
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 52
Secondary outcomes: Visual Analog Scale (VAS) Scales which uses a 10 cm visual scale.
Pain and other outcomes will be assessed at the University of California, Irvine by trained clinical research coordinators. The investigators will have each FM patient complete a 10 cm Visual Analog Scale (VAS) scale with anchors at 0 of "no pain" and 10 as "the worst pain imaginable". A VAS 7 day average recall will be used for inclusion into the study. Patients must score above a 4 on the VAS 7 day recall to be eligible to participate in this study. A daily VAS pain report and present VAS pain report will also be asked during screening, baseline, pre treatment, post treatment assessment visits, and 1-, 3-, and 6-month follow up visits.
Time frame
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 5Other outcomes
1
Exploratory Outcomes: Electrocardiogram (ECG) measured in millivolts and seconds or milliseconds (ms)
The investigators will collect ECG for all FM patients and Shamanic Practitioners (SPs) during all 5 treatment sessions. ECG will be performed using a Movesense sensor (commercially available) connected to a mobile device (via Bluetooth) which runs the patented electrocardio matrix (ECM) software. All data will be securely stored at University of California, Irvine.
Time frame
Treatment Visits 1-5 (To be done over 8 week long period)2
Exploratory Outcomes: Electroencephalogram (EEG) measured in microvolts
The investigators will also collect EEG on patients and SPs during the first and last shamanic treatment session. The investigators will use the BrainVision EEG system to collect brain wave data from patients and SPs during the first and final treatment session. Two caps will be used, one for the patient and one for the SP, with both being attached to the EEG amplifier. All data will be securely stored at University of California, Irvine.
Time frame
Treatment Visits 1-5 (To be done over 8 week long period)3
Exploratory Outcomes: Breathing Rate measured in breaths per minute
The investigators will collect breathing rates for all FM patients and SPs during all 5 treatment sessions. Breathing rate will be measured using a wearable device that does not interfere with the shamanic treatment sessions either. All data will be securely stored at University of California, Irvine.
Time frame
Treatment Visits 1-5 (To be done over 8 week long period)Sponsors and contacts
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Source ClinicalTrials.gov