Is NCT06579261 recruiting in Irvine, CA?

Yes, NCT06579261 is currently recruiting participants at its Irvine, CA location. This fibromyalgia clinical trial is actively enrolling qualified participants.

How do I join the fibromyalgia clinical trial in Irvine?

To join this clinical trial in Irvine, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Irvine clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Fibromyalgia Clinical Trial in Irvine, CA

About This Fibromyalgia Study in Irvine

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.

Sponsor: University of California, Irvine

Who Can Participate

Inclusion Criteria

for Fibromyalgia participants:

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Irvine?

Yes, this clinical trial (NCT06579261) has an active research site in Irvine, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Fibromyalgia Treatment Options in Irvine, CA

If you're searching for fibromyalgia treatment options in Irvine, CA, this clinical trial (NCT06579261) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Irvine research site is actively enrolling participants for this clinical trial. You'll receive care from experienced fibromyalgia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all fibromyalgia clinical trials near you to find additional studies recruiting in your area.

Fibromyalgia Clinical Trial in Irvine, CA

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