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

NCT ID: NCT00952900

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2014-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early Biobehavioral Intervention

This intervention involves the use of non-invasive treatment modalities such as relaxation/biofeedback, stress management, and cognitive coping skills. It is based upon previous clinical research studies demonstrating the efficacy of this intervention in allowing acute TMD patients to better cope with stress and lifestyle issues that produce the TMD pain/discomfort.

Group Type: EXPERIMENTAL

Biobehavioral

Intervention Type: BEHAVIORAL

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

Attention Control Group

This intervention involves the presentation of helpful information to patients that explains etiology and potential treatment modalities used to modify/reduce TMD pain/discomfort.

Group Type: ACTIVE_COMPARATOR

Active Coping/Attention Intervention

Intervention Type: BEHAVIORAL

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.

No Active Treatment Comparison Group

Unlike the other two treatment groups, that involve high-risk acute TMD patients, this group includes low-risk acute TMD patients. Past studies have shown that these low risk patients do not need any early intervention in order to prevent chronicity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biobehavioral

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subject Must be an Adult Aged 18 or Older.
• Subject's First Acute Jaw Pain/Discomfort Episode Must Have First Developed Within the Last 6 Months

Exclusion Criteria

• Younger than 18 years of age
• TMD pain/discomfort of greater than 6 months' duration

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: collaborator

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Robert J. Gatchel

Robert J. Gatchel, Ph.D., ABPP, Professor and Chair, Department of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J. Gatchel, Ph.D., ABPP

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Arlington

Locations

UT Arlington

Arlington, Texas, United States

Countries

United States

Other Identifiers

U01DE010713

Identifier Type: NIH

Identifier Source: secondary_id

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U01DE010713

Identifier Type: NIH

Identifier Source: org_study_id

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