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

Study Overview
=================
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.

Official Title
-----------------
An Implementation and Biobehavioral Study of TMJMD

Conditions
-----------------
Temporomandibular Joint and Muscle Disorder

Intervention / Treatment
-----------------
* Behavioral: Biobehavioral
* Behavioral: Active Coping/Attention Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Biobehavioral Intervention<br>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. | Behavioral: Biobehavioral<br>* 6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.<br>|
| Active Comparator: Attention Control Group<br>This intervention involves the presentation of helpful information to patients that explains etiology and potential treatment modalities used to modify/reduce TMD pain/discomfort. | Behavioral: Active Coping/Attention Intervention<br>* 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.<br>|
| No Intervention: No Active Treatment Comparison Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute TMJMD does not progress to chronic |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TMJMD, Acute Pain, RDC/TMD, Community Treatment Clinics, Evidence-Based Outcomes, Short- and long-term follow-up, Biopsychosocial, Assessment and Treatment, Ability to read and write English, 6 months' or less duration of TMD, No other pain-related conditions, RCT