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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
Robert J. Gatchel, The University of Texas at Arlington
ClinicalTrials.gov Identifier:
NCT00952900
First received: August 3, 2009
Last updated: May 21, 2014
Last verified: May 2014

August 3, 2009
May 21, 2014
August 2008
July 2014   (final data collection date for primary outcome measure)
Acute TMJMD does not progress to chronic [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952900 on ClinicalTrials.gov Archive Site
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An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)
An Implementation and Biobehavioral Study of 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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Temporomandibular Joint and Muscle Disorder
  • 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.
  • Experimental: 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.
    Intervention: Behavioral: Biobehavioral
  • Active Comparator: 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.
    Intervention: Behavioral: Active Coping/Attention Intervention
  • No Intervention: 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
675
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952900
U01 DE 010713, U01 DE 010713
Yes
Robert J. Gatchel, The University of Texas at Arlington
The University of Texas at Arlington
Texas A&M University
Principal Investigator: Robert J. Gatchel, Ph.D., ABPP The University of Texas at Arlington
The University of Texas at Arlington
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP