Alternative Medicine Approaches for Women With Temporomandibular Disorders

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00009594
First received: February 1, 2001
Last updated: August 17, 2006
Last verified: August 2006
  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 Alternative Medicine (NCCAM):

Study Start Date: September 1999
Estimated Study Completion Date: July 2004
Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009594

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

No publications provided

ClinicalTrials.gov Identifier: NCT00009594     History of Changes
Obsolete Identifiers: NCT00009282
Other Study ID Numbers: P50 AT000076-01P2, P50AT000076-01
Study First Received: February 1, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014