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Alternative Medicine Approaches for Women With Temporomandibular Disorders

Alternative Medicine Approaches for Women With Temporomandibular Disorders

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00009594
Enrollment
Unknown
Registered
2001-02-02
Start date
1999-09-30
Completion date
2004-07-31
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

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.

Detailed description

See brief summary

Interventions

PROCEDURETraditional Chinese Medicine

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026