An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)

NCT00952900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2015-06-08

No results posted yet for this study

Summary

With the great economic costs and traditionally poor outcomes among chronic temporomandibular joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the acute state, in order to prevent these more chronic disability problems. This has been the goal of two past funded grant projects. Results of the initial project isolated risk factors that successfully predicted the development of chronicity with a 91% accuracy rate. A statistical algorithm was developed which was used in the second project to screen out "high-risk" patients. These patients were then randomly assigned an early intervention or non-intervention group. One-year follow-up evaluations documented the treatment efficacy and cost effectiveness of early intervention. These results have major implications for effective early intervention and significant health care cost savings for this prevalent pain and disability problem. For the present proposed project, we plan to implement this treatment program in order to evaluate its effectiveness in more community-based dental practices. This is in response to NIH's request for the implementation of evidence-based treatment approaches, developed in controlled clinical settings, to the "real world" of diverse practices in the community. Acute TMJMD patients will be recruited from two community-based clinics. Based upon our "risk" screening algorithm, high-risk patients will be randomly assigned to one of two groups (n=225/group): an early biobehavioral intervention or an attention-control group. It is hypothesized that the attention control "high-risk" patients will display more chronic TMJMD problems, relative to the "high-risk" early intervention patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc. Such a multi-level, multi-systems approach has not been applied to better understand the biopsychosocial underpinnings of TMJMD. Results from this component of the project will greatly aid in stimulating future research leading to the better understanding of TMJMD, as well as better tailoring of prescribed treatment regimens.

Conditions

  • Temporomandibular Joint and Muscle Disorder

Interventions

BEHAVIORAL

Biobehavioral

6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.

BEHAVIORAL

Active Coping/Attention Intervention

6 sessions of didactic educational techniques to expose patients to the causes of TMD, as well as introducing them to traditional treatment modalities for intervening with acute TMD problems.

Sponsors & Collaborators

Principal Investigators

  • Robert J. Gatchel, Ph.D., ABPP · The University of Texas at Arlington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-10-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952900 on ClinicalTrials.gov