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

Primary Purpose

Temporomandibular Joint and Muscle Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biobehavioral
Active Coping/Attention Intervention
Sponsored by
The University of Texas at Arlington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Temporomandibular Joint and Muscle Disorder focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UT Arlington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Early Biobehavioral Intervention

Attention Control Group

No Active Treatment Comparison Group

Arm Description

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.

This intervention involves the presentation of helpful information to patients that explains etiology and potential treatment modalities used to modify/reduce TMD pain/discomfort.

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.

Outcomes

Primary Outcome Measures

Acute TMJMD does not progress to chronic

Secondary Outcome Measures

Full Information

First Posted
August 3, 2009
Last Updated
June 3, 2015
Sponsor
The University of Texas at Arlington
Collaborators
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT00952900
Brief Title
An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)
Official Title
An Implementation and Biobehavioral Study of TMJMD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Arlington
Collaborators
Texas A&M University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Biobehavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
This intervention involves the presentation of helpful information to patients that explains etiology and potential treatment modalities used to modify/reduce TMD pain/discomfort.
Arm Title
No Active Treatment Comparison Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biobehavioral
Intervention Description
6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.
Intervention Type
Behavioral
Intervention Name(s)
Active Coping/Attention Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute TMJMD does not progress to chronic
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Gatchel, Ph.D., ABPP
Organizational Affiliation
The University of Texas at Arlington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76019
Country
United States

12. IPD Sharing Statement

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

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