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

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

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

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

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

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]

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]

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 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 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]

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]

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]

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 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]

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]

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]

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]