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Alternative Medicine Approaches for Women With Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naturopathic Medicine
Traditional Chinese Medicine
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Temporomandibular Joint Disorders

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Health Research, Kaiser Foundation Hospitals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 1, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00009594
Brief Title
Alternative Medicine Approaches for Women With Temporomandibular Disorders
Official Title
Alternative Medicine Approaches for Women With Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. 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.
Detailed Description
See brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Naturopathic Medicine
Intervention Type
Procedure
Intervention Name(s)
Traditional Chinese Medicine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander White
Organizational Affiliation
Center for Health Research (CHR), Kaiser Foundation Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Research, Kaiser Foundation Hospitals
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1110
Country
United States

12. IPD Sharing Statement

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Alternative Medicine Approaches for Women With Temporomandibular Disorders

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