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Alternative Medicine Approaches for Women With Temporomandibular Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00009594
First Posted: February 2, 2001
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  Purpose

Temporomandibular disorders (TMD) are characterized by pain and tenderness in the muscles of mastication and/or the temporomandibular joint (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds.

TMD is often found in association with other problems: depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infections, etc. This project proposes to holistically address patient symptoms through three different approaches, Naturopathic Medicine (NM), Traditional Chinese Medicine (TCM), and usual care at KPNW. We will conduct a pilot test and Phase II trial to evaluate the two alternative healing approaches, TCM (n=50) and NM (n=50) delivered by TCM and NM practitioners, are as effective as usual TMD care (n=50) provided by dental clinicians in the KPNW TMD Clinic. Subjects will be females 25-55 years of age with multiple health problems (defined as patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD). Subjects will be evaluated at baseline, 6 and 12 months after start of treatment. The primary endpoint is change from baseline in the Axis II Pain Related Disability and Psychological Status Scale. Clinical examinations, saliva samples to assess salivary cortisol levels, and responses to a series of questionnaires to assess pain, chronic pain, psychosocial functioning, and other physical symptoms will be used to assess outcomes. We will passively monitor health care utilization within KPNW using clinical, research, and administrative databases to determine whether the interventions have an impact on overall health care utilization. If either of these alternative interventions is shown to merit Phase III trial, our goal is to design and implement such a clinical trial to further evaluate the health consequences and costs of these alternative healing paradigms.


Condition Intervention Phase
Temporomandibular Joint Disorders Procedure: Naturopathic Medicine Procedure: Traditional Chinese Medicine Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Alternative Medicine Approaches for Women With Temporomandibular Disorders

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Study Start Date: September 1999
Estimated Study Completion Date: July 2004
Detailed Description:
See brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
- Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009594


Locations
United States, Oregon
Center for Health Research, Kaiser Foundation Hospitals
Portland, Oregon, United States, 97227-1110
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Alexander White Center for Health Research (CHR), Kaiser Foundation Hospitals
  More Information

ClinicalTrials.gov Identifier: NCT00009594     History of Changes
Obsolete Identifiers: NCT00009282
Other Study ID Numbers: P50AT000076-01P2 ( U.S. NIH Grant/Contract )
P50AT000076-01 ( U.S. NIH Grant/Contract )
First Submitted: February 1, 2001
First Posted: February 2, 2001
Last Update Posted: August 18, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease
Joint Diseases
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes