Core Shamanism for Fibromyalgia

Overseen By University of California, Irvine Susan Samueli Integrative Health Institute

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Opioids, Marijuana, Stimulants, NSAIDs

Disqualifiers: Autoimmune diseases, Head injury, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a shamanism intervention (Core Shamanism) can reduce pain and other symptoms in people with fibromyalgia, a condition that causes widespread pain and fatigue. Researchers aim to determine if this treatment affects heart rate, breathing, and brain waves. Women with fibromyalgia who experience significant pain and can travel for treatment are potential candidates for this study. As an unphased trial, this study provides a unique opportunity to explore alternative treatments and contribute to innovative research in managing fibromyalgia symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to limit starting any new medications or treatments for fibromyalgia during the study. Some medications, like opioid painkillers and certain stimulants, are not allowed.

What prior data suggests that this shamanism intervention is safe for fibromyalgia patients?

Research shows no specific safety information available for Core Shamanism in humans. This absence means detailed reports on how people handle the treatment or any side effects are lacking. The trial is in a phase labeled "Not Applicable," indicating an early or exploratory study. This phase suggests a focus on feasibility rather than thorough safety testing. As a spiritual practice, Core Shamanism might be less physically invasive than some medical treatments, but this does not automatically ensure safety. Participants should consider this when deciding to join the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Core Shamanism for fibromyalgia because it offers a completely different approach from the usual medications like pain relievers, antidepressants, and anti-seizure drugs. Core Shamanism focuses on spiritual and psychological healing practices, aiming to treat the mind-body connection, which is often overlooked in traditional treatments. This method could provide relief by addressing emotional and spiritual well-being, potentially reducing pain and improving quality of life without the side effects usually associated with medication.

What evidence suggests that Core Shamanism might be an effective treatment for fibromyalgia?

Research suggests that shamanic practices might help manage fibromyalgia symptoms, although strong evidence is still developing. This trial will provide participants with a shamanic intervention. Some studies on similar conditions, such as jaw disorders, have shown that shamanic healing might reduce pain and improve well-being. Shamanism may alter brain waves, heart rate, and breathing patterns, potentially helping the body function more harmoniously and easing discomfort. While more research is needed, the possibility that shamanism can affect both physical and mental states offers hope for those with chronic pain conditions like fibromyalgia. ^{1 3 5 6 7}

Who Is on the Research Team?

Richard E Richard, PhD

Principal Investigator

UCI SSIHI

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am female.

My average pain level in the past week was 4 or higher on a scale of 10.

I can go to the study location for treatments up to twice a week.

Exclusion Criteria

I have nerve pain or tingling that affects my daily activities.

History of head injury with substantial loss of consciousness

Any impairment, activity, or situation that may hinder study protocol completion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an 8-week shamanism intervention with 5 one-on-one treatment sessions involving classical and drumming music, ECG, and breathing rate measurements

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for durability of treatment response with questionnaires at 1-, 3-, and 6-month intervals

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Core Shamanism

Trial Overview 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.

How Is the Trial Designed?

Group I: Fibromyalgia participants - Shamanic Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

A systematic review of 70 clinical trials on complementary and alternative medicine (CAM) for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) found that 86% of studies reported at least one positive effect from the interventions, indicating potential efficacy.

Acupuncture, meditative practices, and certain supplements like magnesium and l-carnitine showed the most promise for future research, although the overall methodological quality of the studies was poor, preventing firm conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative medical interventions used in the treatment and management of myalgic encephalomyelitis/chronic fatigue syndrome and fibromyalgia. Porter, NS., Jason, LA., Boulton, A., et al.[2019]

This Canadian study identified and classified various risk-associated alternative health practices through a Delphi study involving 17 health experts, highlighting the need for a clear definition and taxonomy of alternative health care.

The research revealed that some alternative health practices can lead to significant harms, including major physical injuries or even death, emphasizing the importance of understanding the risks involved in alternative health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A taxonomy of risk-associated alternative health practices: A Delphi study. Garrett, B., Caulfield, T., Murdoch, B., et al.[2022]

A new adverse events (AEs) reporting form specifically designed for Korean folk medicine has been developed, incorporating unique characteristics such as folk medicine properties and patient information.

This reporting form is the first of its kind and aims to improve the tracking and understanding of adverse events related to Korean folk medicine, enhancing safety and efficacy monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse events reporting form for Korean folk medicine. Park, JH., Choi, SM., Moon, S., et al.[2021]

A systematic review of complementary and alternative medicine (CAM) for fibromyalgia syndrome (FMS) found that acupuncture, certain herbal and nutritional supplements (like magnesium and SAMe), and massage therapy have the strongest evidence for effectiveness.

Many other CAM therapies either lack robust studies or have shown mixed results, with some, like chiropractic care, not recommended due to insufficient evidence of benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine in fibromyalgia and related syndromes. Holdcraft, LC., Assefi, N., Buchwald, D.[2022]

A pilot study involving 48 patients with fibromyalgia found that a multimodal Integrative Medicine (IM) approach, which included fasting therapy, led to significant short-term improvements in fibromyalgia symptoms compared to a conventional rheumatology (CM) approach after 2 weeks.

While the IM approach showed benefits in reducing symptoms like pain and anxiety initially, these effects diminished after 12 weeks, suggesting that while IM may be effective in the short term, further research is needed to evaluate its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy. Michalsen, A., Li, C., Kaiser, K., et al.[2021]

A pilot study involving 31 women with fibromyalgia showed significant long-term reductions in symptoms after 24 months of treatment at the Maharishi Ayurveda Health Centre, with improvements in six out of seven fibromyalgia dimensions, including pain and anxiety.

Participants who practiced Transcendental Meditation (TM) reported almost no symptoms and had significantly better outcomes compared to those who did not meditate, suggesting that TM may enhance the efficacy of the treatment program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway II--a 24-month follow-up pilot study. Rasmussen, LB., Mikkelsen, K., Haugen, M., et al.[2021]

Mind-body techniques, such as biofeedback and cognitive behavioral therapy, show the strongest evidence for effectively treating fibromyalgia, especially when part of a multidisciplinary treatment plan.

Acupuncture has moderate support for fibromyalgia treatment, but it can sometimes worsen symptoms for certain patients, highlighting the need for careful application and further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary medicine treatments for fibromyalgia syndrome. Berman, BM., Swyers, JP.[2018]

The Canadian adverse event reporting system for herbal products is severely underreported, leading to a lack of safety data, which poses risks to consumers who often perceive these products as safe.

Health food store personnel in the Greater Toronto Area play a crucial role in reporting adverse reactions by collecting customer information during product returns, suggesting a potential pathway to improve safety monitoring and reporting for herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. Walji, R., Boon, H., Barnes, J., et al.[2021]

Pharmacists in Toronto reported that they rarely submitted adverse event reports for natural health products (NHPs) due to barriers like time constraints, complexity of the reporting process, and limited knowledge about these products.

Those pharmacists who did take responsibility for reporting suspected adverse drug reactions viewed themselves as contributors to healthcare knowledge, indicating that their professional identity influences their reporting behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting natural health product related adverse drug reactions: is it the pharmacist's responsibility? Walji, R., Boon, H., Barnes, J., et al.[2011]

A review of 23 randomized controlled trials (RCTs) on various complementary and alternative medicine therapies showed that balneotherapy/hydrotherapy had the strongest evidence for effectiveness, while the overall quality of the studies was relatively low, with an average methodological quality score of 51 out of 100.

Positive outcomes were also observed for homeopathy and mild infrared hyperthermia in individual studies, while acupuncture showed mixed results, indicating that some alternative therapies may have potential benefits but require further high-quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Baranowsky, J., Klose, P., Musial, F., et al.[2023]

In a feasibility study involving 32 patients (21 receiving Ayurvedic treatment and 11 receiving conventional treatment), both groups showed significant improvements in fibromyalgia symptoms after two weeks, with no significant differences between the two approaches.

The benefits of both treatments were partially maintained at a 6-month follow-up, suggesting that Ayurvedic therapy may be as effective as conventional treatment for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial). Kessler, CS., Ostermann, T., Meier, L., et al.[2021]

The study found that an 8-week second-generation mindfulness-based intervention (SG-MBI) called meditation awareness training (MAT) significantly improved symptoms of fibromyalgia syndrome (FMS), including pain perception and sleep quality, in 74 participants compared to a control group.

Improvements in FMS symptoms were linked to reduced attachment to self and increased civic engagement, suggesting that these psychological factors play a crucial role in the effectiveness of SG-MBIs for treating FMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. Van Gordon, W., Shonin, E., Dunn, TJ., et al.[2022]

A systematic review of 25 studies on complementary and alternative medicine (CAM) for fibromyalgia syndrome (FMS) found consistently positive results for therapies like tai chi, yoga, and mindfulness, indicating their potential effectiveness in managing FMS symptoms.

However, the overall methodological quality of the reviews varied significantly, with many showing flaws that limit the ability to draw definitive conclusions about the efficacy and safety of CAM therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Overview of Reviews for Complementary and Alternative Therapies in the Treatment of the Fibromyalgia Syndrome. Lauche, R., Cramer, H., Häuser, W., et al.[2022]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Citations

1. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06579261

Core Shamanism in Fibromyalgia This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism ...

2. withpower.com withpower.com/trial/core-shamanism-for-fibromyalgia-ad951

Core Shamanism for Fibromyalgia This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3383158/

Long-term Outcomes of Shamanic Treatment for ... A phase I study that evaluated the feasibility and efficacy of shamanic healing for people with TMDs.

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/218/fibromyalgia?page=2

Fibromyalgia Clinical Research Trials The Effects of Core Shamanism in Fibromyalgia. This study includes an 8-week long intervention, with 5 one-on-one treatment sessions with Fibromyalgia (FM) ...

5. faculty.sites.uci.edu faculty.sites.uci.edu/harrislab/research/

Studies – Harris Lab Current studies focus on the roles of acupuncture/acupressure, meditation, and shamanism in the reduction of chronic pain and how these interventions work on ...

6. trialx.com trialx.com/clinical-trials/listings/316459/the-effects-of-core-shamanism-in-fibromyalgia/

The Effects of Core Shamanism in Fibromyalgia Overview. This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if ...

7. smartpatients.com smartpatients.com/trials/NCT06579261

The Effects of Core Shamanism in Fibromyalgia This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism ...