Clinical trial NCT00952900: An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)
Official title: An Implementation and Biobehavioral Study of TMJMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint and Muscle Disorder
Keywords: 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
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2009-08-06
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Acute TMJMD does not progress to chronic
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UT Arlington
state: Texas
Study officials:
affiliation: The University of Texas at Arlington
name: Robert J. Gatchel, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
References: