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Alternative Medicine Approaches for Women With Temporomandibular Disorders
This study has been completed.
Study NCT00009594   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 1, 2001   Last Updated: August 17, 2006   History of Changes

February 1, 2001
August 17, 2006
September 1999
 
 
 
Complete list of historical versions of study NCT00009594 on ClinicalTrials.gov Archive Site
 
 
 
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

Phase II
Interventional
Diagnostic
Temporomandibular Joint Disorders
  • Procedure: Naturopathic Medicine
  • Procedure: Traditional Chinese Medicine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
July 2004
 
  • Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD
Female
25 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009594
 
P50 AT000076-01P2, P50AT000076-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Alexander White Center for Health Research (CHR), Kaiser Foundation Hospitals
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

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