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

An Implementation and Biobehavioral Study of TMJMD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00952900
Enrollment
456
Registered
2009-08-06
Start date
2008-08-31
Completion date
2014-07-31
Last updated
2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALBiobehavioral

6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.

BEHAVIORALActive 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.

Sponsors

Texas A&M University
CollaboratorOTHER
The University of Texas at Arlington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Acute TMJMD does not progress to chronic24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026