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
  Purpose

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.


Condition Intervention
Temporomandibular Joint and Muscle Disorder
Behavioral: Biobehavioral
Behavioral: Active Coping/Attention Intervention

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

Resource links provided by NLM:


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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Biobehavioral
6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.
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.
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952900

Locations
United States, Texas
UT Arlington
Arlington, Texas, United States, 76019
Sponsors and Collaborators
The University of Texas at Arlington
Texas A&M University
Investigators
Principal Investigator: Robert J. Gatchel, Ph.D., ABPP The University of Texas at Arlington
  More Information

No publications provided

Responsible Party: Robert J. Gatchel, Robert J. Gatchel, Ph.D., ABPP, Professor and Chair, Department of Psychology, The University of Texas at Arlington
ClinicalTrials.gov Identifier: NCT00952900     History of Changes
Other Study ID Numbers: U01 DE 010713, U01 DE 010713
Study First Received: August 3, 2009
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas at Arlington:
TMJMD
Acute Pain
RDC/TMD
Community Treatment Clinics
RCT
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

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014