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NCT00009594 · ClinicalTrials.gov registry record · Phase 2
Alternative Medicine Approaches for Women With Temporomandibular Disorders
A Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00009594 is a Phase 2 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH).
The verdict
NCT00009594, a Phase 2 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study 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.
Interventions
- PROCEDURE Naturopathic Medicine
- PROCEDURE Traditional Chinese Medicine
Trial Details
| Field | Value |
|---|---|
| Start Date | 1999-09 |
| Est. Completion | 2004-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009594
The ClinicalTrials.gov registry entry for NCT00009594 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naturopathic Medicine is the first listed.
NCT00009594 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009594 about?
NCT00009594 is a clinical study titled "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 associ...
What is the current status of trial NCT00009594?
This trial is currently completed. It is a Phase 2 study. The study started on 1999-09. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00009594?
The interventions under investigation include: Naturopathic Medicine (PROCEDURE), Traditional Chinese Medicine (PROCEDURE).
Who is sponsoring clinical trial NCT00009594?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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