Core Shamanism for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen by Richard E Richard, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Irvine

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

Disqualifiers: Autoimmune diseases, Head injury, Neuropathy, others

No Placebo Group

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Core Shamanism for fibromyalgia?

Research on similar treatments, like mindfulness meditation and Ayurvedic therapy, shows positive results in reducing fibromyalgia symptoms such as pain and anxiety. These treatments, which also incorporate spiritual or holistic elements, suggest that Core Shamanism might offer similar benefits. ^{1 2 3 4 5}

Is Core Shamanism safe for humans?

There is no specific safety data available for Core Shamanism or similar practices like Harner Shamanism and Neoshamanism. However, alternative health practices, in general, are not necessarily risk-free, and some may pose significant risks, including physical injuries or even death. ^{6 7 8 9 10}

How does the treatment Core Shamanism differ from other treatments for fibromyalgia?

Core Shamanism is unique because it involves spiritual and ritualistic practices that aim to heal through altered states of consciousness, unlike other treatments for fibromyalgia that focus on physical or mind-body techniques like acupuncture or meditation. This approach is novel as it taps into spiritual healing, which is not commonly explored in conventional or other complementary treatments for fibromyalgia. ^{1 11 12 13 14}

Research Team

Richard E Richard, PhD

Principal Investigator

UCI SSIHI

Eligibility Criteria

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 agree not to start new treatments for my FM symptoms during the study.

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

Trial Timeline

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)

Treatment Details

Interventions

• Core Shamanism (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Susan Samueli Integrative Health Institute Irvine, CA

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Patients Recruited

4,943,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway II--a 24-month follow-up pilot study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. [2023]

5. United States 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). [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Reporting natural health product related adverse drug reactions: is it the pharmacist's responsibility? [2011]

9. England pubmed.ncbi.nlm.nih.gov

A taxonomy of risk-associated alternative health practices: A Delphi study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Development of an adverse events reporting form for Korean folk medicine. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine in fibromyalgia and related syndromes. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Alternative medical interventions used in the treatment and management of myalgic encephalomyelitis/chronic fatigue syndrome and fibromyalgia. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Complementary medicine treatments for fibromyalgia syndrome. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

A Systematic Overview of Reviews for Complementary and Alternative Therapies in the Treatment of the Fibromyalgia Syndrome. [2022]