- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00071474
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
January 22, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens.
Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions.
Traditional treatment outcomes for TMD pain are often unsatisfactory.
Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia.
Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance.
This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing.
Study Type
Interventional
Enrollment
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States
- Center for Health Research, Northwest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- Females Age 25-55
- TMD Research Diagnosis Criteria (RDC) clinical diagnosis of myofacial pain with or without disc displacement, arthralgia, arthritis, or arthosis
- Three or more significant systemic conditions, e.g. depression, fibromyalgia, GI or reproductive disturbances, upper respiratory problems, etc. in the preceding 2 years.
Exclusion criteria:
- Diagnosed organic or medication induced major mental illness (e.g., schizophrenia, bipolar)
- Other neurological diagnoses (epilepsy, Parkinsons)
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nancy Vuckovic, MD, Center for Health Research, Northwest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
October 23, 2003
First Submitted That Met QC Criteria
October 23, 2003
First Posted (Estimate)
October 24, 2003
Study Record Updates
Last Update Posted (Estimate)
January 24, 2007
Last Update Submitted That Met QC Criteria
January 22, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000951-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Temporomandibular Disorders
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University of Nove de JulhoUnknownTemporomandibular DisorderBrazil
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Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular Disorder | Temporomandibular Joint Pain | Manual Therapy | Temporomandibular Joint Disc DisplacementTurkey
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Yeditepe UniversityUnknownTemporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing) | Osteopathy in Temporomandibular DisordersTurkey
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University of ValenciaCompletedTemporomandibular Dysfunction (TMD)Spain
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Beirut Arab UniversityRecruitingTemporomandibular DisorderLebanon
-
Riphah International UniversityRecruitingTemporomandibular DisorderPakistan
-
Hams Hamed AbdelrahmanCompletedTemporomandibular DisorderEgypt
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Centre Hospitalier Universitaire de NiceCompleted
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Federal University of Rio Grande do SulCompletedTemporomandibular Disorder
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University of Nove de JulhoCompleted
Clinical Trials on shamanic healing
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Henning BliddalOak Foundation; The Danish Rheumatism Association; The IMK FoundationCompletedRheumatoid Arthritis
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Ana Molina VillarUnknown
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Alexandria UniversityCompleted
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Ain Shams UniversityNot yet recruitingDental Implants
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Harvard UniversityCompleted
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Shriners Hospitals for ChildrenCompleted