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Completed

NCT Number: NCT00952900

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Arlington

Arlington, Texas, 76019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biobehavioral

Behavioral

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

Active Coping/Attention Intervention

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.

Primary outcomes

  1. Acute TMJMD does not progress to chronic

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Collaborators

  • Texas A&M University

Registry information

Official study title

An Implementation and Biobehavioral Study of TMJMD

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 6, 2009
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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