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Brief Treatment for Temporomandibular Pain

Primary Purpose

Temporomandibular Joint Syndrome, Myofascial Pain Dysfunction Syndrome, Orofacial Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral treatment
Attention and lifestyle counseling
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Complaining of chronic TM-related pain for at least 3 months Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment Fluency in English Exclusion Criteria: No previous surgery for treatment of TMD pain No history of rheumatoid disease No extensive anatomical destruction or deterioration of the TM joint Not diagnosed as having pain of neuropathic or odontogenic origin Not carrying a diagnosis of psychosis No current treatment for depression Not taking narcotic pain medication Not pregnant

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coping Skills Training

Standard Care

Arm Description

manualized coping skills training delivered along with conservative care

Attention and life counseling added to Standard conservative care

Outcomes

Primary Outcome Measures

Pain
Multidimensional pain ratings collected in person every 3 months
Pain-related interference with functioning
Multidimensional function ratings collected in person every 3 months
Depressive symptoms
CES-D depressive symtpoms scale administered in perosn every 3 months.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2003
Last Updated
July 27, 2017
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT00067366
Brief Title
Brief Treatment for Temporomandibular Pain
Official Title
Brief Focused Treatment for TMD: Mechanisms of Action
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health

4. Oversight

5. Study Description

Brief Summary
Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.
Detailed Description
TMD is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment. Men and women (N=106) with complaints of chronic facial pain for at least 3 months' duration will be recruited from the University Dental Clinics and from the community via advertisements and randomly assigned to either a Standard Conservative Treatment (STD) employing an intraoral splint plus anti-inflammatory agents, or to a Standard Treatment + Cognitive-Behavioral Treatment Program (STD+CBT), that will include standard treatment but also focus on changing self-efficacy and decreasing catastrophization. Both treatments will entail 6 clinic visits. Dispositional and situational variables derived from a comprehensive model of pain coping will be measured before and after treatment. The situational variables, including coping responses, mood states, situational appraisals and self-efficacy, will be measured in an experience sampling paradigm four times daily using a hand-held computer. This will be done to minimize retrospective biases that may have hampered earlier studies of treatment process. Dependent variables will be self-report measures of distress, pain, and interference with activities, as well as blood plasma levels of cortisol and selected cytokines, measured at the end of the 6-week treatment period, and at follow-up points thereafter up to a 12-month follow-up. It is expected that the STD+CBT treatment will result in measurable changes in constructs such as self-efficacy and catastrophization, and that these changes will be related to improved outcomes compared to the STD controls. It is also expected that outcome differences between groups will be associated with changes in inflammatory mediators (cytokine levels). Finally, it is suggested that changes in situational treatment process variables will be associated with changes in cytokine levels. The results may indicate the true active mechanisms of successful TMD treatment. If these mechanisms can be successfully identified it would have important implications for the development of more effective treatment programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Syndrome, Myofascial Pain Dysfunction Syndrome, Orofacial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping Skills Training
Arm Type
Experimental
Arm Description
manualized coping skills training delivered along with conservative care
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Attention and life counseling added to Standard conservative care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral treatment
Intervention Description
Cognitive-Behavioral skills training for chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Attention and lifestyle counseling
Intervention Description
Attention and lifestyle counseling added to Standard Care
Primary Outcome Measure Information:
Title
Pain
Description
Multidimensional pain ratings collected in person every 3 months
Time Frame
Every 3 months out to 12 months
Title
Pain-related interference with functioning
Description
Multidimensional function ratings collected in person every 3 months
Time Frame
every 3 months out to 12 months
Title
Depressive symptoms
Description
CES-D depressive symtpoms scale administered in perosn every 3 months.
Time Frame
Every 3 months out to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complaining of chronic TM-related pain for at least 3 months Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment Fluency in English Exclusion Criteria: No previous surgery for treatment of TMD pain No history of rheumatoid disease No extensive anatomical destruction or deterioration of the TM joint Not diagnosed as having pain of neuropathic or odontogenic origin Not carrying a diagnosis of psychosis No current treatment for depression Not taking narcotic pain medication Not pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Litt, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Brief Treatment for Temporomandibular Pain

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