An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)
This study is currently recruiting participants.
Verified by The University of Texas at Arlington, August 2009
First Received: August 3, 2009 Last Updated: August 5, 2009
|The University of Texas at Arlington|
|Texas A&M University|
Information provided by:
|The University of Texas at Arlington|
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.
Temporomandibular Joint and Muscle Disorder
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention Official Title: An Implementation and Biobehavioral Study of TMJMD
Further study details as provided by The University of Texas at Arlington:
Primary Outcome Measures:
- Acute TMJMD does not progress to chronic [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 675
Study Start Date: August 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
|Early Biobehavioral Intervention: Experimental
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. Intervention: Behavioral: Biobehavioral
Behavioral: Biobehavioral 6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.
Attention Control Group: Active Comparator
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.
|No Active Treatment Comparison Group: No Intervention
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.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
- Subject Must be an Adult Aged 18 or Older.
- Subject Must be Able to Read and Speak English Because the Assessment and Treatment Methods we Are Using Cannot be Translated Into Another Language.
- Subject's First Acute Jaw Pain/Discomfort Episode Must Have First Developed Within the Last 6 Months
- Younger than 18 years of age
- Cannot read or speak English
- TMD pain/discomfort of greater than 6 months' duration