Alternative Medicine Approaches for Women With Temporomandibular Disorders

• Sponsor: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00009594
• Collaborator: (none)
• Location: 1
• Duration (Months): 58

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders	Procedure: Naturopathic Medicine; Procedure: Traditional Chinese Medicine	Phase 2

Detailed Description

See brief summary

Study Design

• Study Type: Interventional
• Primary Purpose: Diagnostic
• Official Title: Alternative Medicine Approaches for Women With Temporomandibular Disorders
• Study Start Date: Sep 1, 1999
• Study Completion Date: Jul 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

• Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00009594
• Other Study ID Numbers: P50AT000076-01P2; P50AT000076-01; NCT00009282
• First Posted: Feb 2, 2001
• Last Update Posted: Aug 18, 2006
• Last Verified: Aug 1, 2006

• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases

Study Results

No Results Posted as of Aug 18, 2006