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Complementary Medicine Approaches to TMD Pain Management

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Complementary Medicine Approaches to TMD Pain Management

Official Title ^†

Complementary Medicine Approaches to TMD Pain Management

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Temporomandibular Joint Disorders

Intervention ^†

Procedure: Acupuncture
Procedure: chiropractic therapy
Procedure: bodywork therapy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 1999

Completion Date

July 2004

Eligibility Criteria ^†

Inclusion Criteria:

Psychologically functional TMD patients

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00010621

Organization ID

P50 AT000076-01P1

Secondary IDs ^††

P50 AT000076-01

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Alex White

Center for Health Research (CHR), Kaiser Foundation Hospitals

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

February 2, 2001

Last Updated Date

August 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.