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Alternative Medicine Approaches for Women With Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT00009594
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

February 1, 2001
February 2, 2001
August 18, 2006
September 1999
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Complete list of historical versions of study NCT00009594 on ClinicalTrials.gov Archive Site
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Alternative Medicine Approaches for Women With Temporomandibular Disorders
Alternative Medicine Approaches for Women With Temporomandibular Disorders

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.

See brief summary
Interventional
Phase 2
Primary Purpose: Diagnostic
Temporomandibular Joint Disorders
  • Procedure: Naturopathic Medicine
  • Procedure: Traditional Chinese Medicine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004
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- Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD
Sexes Eligible for Study: Female
25 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00009594
P50AT000076-01P2( U.S. NIH Grant/Contract )
P50AT000076-01 ( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Alexander White Center for Health Research (CHR), Kaiser Foundation Hospitals
National Center for Complementary and Integrative Health (NCCIH)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP