Complementary Medicine Approaches to TMD Pain Management
Primary Purpose
Temporomandibular Joint Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
chiropractic therapy
bodywork therapy
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders
Eligibility Criteria
Inclusion Criteria: Psychologically functional TMD patients
Sites / Locations
- Center for Health Research
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010621
First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010621
Brief Title
Complementary Medicine Approaches to TMD Pain Management
Official Title
Complementary Medicine Approaches to TMD Pain Management
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
This study will determine whether selected complementary approaches to temporomandibular joint (TMJ) pain management-acupuncture are as effective as usual care.
Detailed Description
Temporomandibular disorders are characterized by pain and tenderness in the muscles of mastication and/or the (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds. This study will compare the effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the standard of care for TMJ pain. If these complementary interventions are shown to be effective, the goal is to design and implement a Phase III clinical trial to further evaluate the health consequences and cost of these therapies.
Participants will be evaluated at baseline, and 6 and 12 months post-intervention. Clinical examinations, saliva samples to assess salivary cortisol levels, and a series of questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and other physical symptoms will be used to assess outcomes. The investigators will passively monitor health care utilization within KPNW using clinical, research, and administrative databases.
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
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Procedure
Intervention Name(s)
chiropractic therapy
Intervention Type
Procedure
Intervention Name(s)
bodywork therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Psychologically functional TMD patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex White
Organizational Affiliation
Center for Health Research (CHR), Kaiser Foundation Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1110
Country
United States
12. IPD Sharing Statement
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Complementary Medicine Approaches to TMD Pain Management
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