Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
Primary Purpose
Temporomandibular Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
shamanic healing
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders focused on measuring temporomandibular disroders, shamanism, chronic pain
Eligibility Criteria
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
Sites / Locations
- Center for Health Research, Northwest
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00071474
First Posted
October 23, 2003
Last Updated
January 22, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00071474
Brief Title
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
temporomandibular disroders, shamanism, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
shamanic healing
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Vuckovic, MD
Organizational Affiliation
Center for Health Research, Northwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Research, Northwest
City
Portland
State/Province
Oregon
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
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