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Brief Treatment for Temporomandibular Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067366
First Posted: August 19, 2003
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Litt, UConn Health
  Purpose
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.

Condition Intervention
Temporomandibular Joint Syndrome Myofascial Pain Dysfunction Syndrome Orofacial Pain Behavioral: Cognitive-Behavioral treatment Behavioral: Attention and lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Focused Treatment for TMD: Mechanisms of Action

Further study details as provided by Mark Litt, UConn Health:

Primary Outcome Measures:
  • Pain [ Time Frame: Every 3 months out to 12 months ]
    Multidimensional pain ratings collected in person every 3 months

  • Pain-related interference with functioning [ Time Frame: every 3 months out to 12 months ]
    Multidimensional function ratings collected in person every 3 months

  • Depressive symptoms [ Time Frame: Every 3 months out to 12 months ]
    CES-D depressive symtpoms scale administered in perosn every 3 months.


Enrollment: 116
Study Start Date: October 2003
Study Completion Date: September 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Skills Training
manualized coping skills training delivered along with conservative care
Behavioral: Cognitive-Behavioral treatment
Cognitive-Behavioral skills training for chronic pain
Active Comparator: Standard Care
Attention and life counseling added to Standard conservative care
Behavioral: Attention and lifestyle counseling
Attention and lifestyle counseling added to Standard Care

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067366


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
Principal Investigator: Mark D Litt, Ph.D. UConn Health
  More Information

Responsible Party: Mark Litt, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT00067366     History of Changes
Other Study ID Numbers: NIDCR-14607
First Submitted: August 15, 2003
First Posted: August 19, 2003
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Syndrome
Facial Pain
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Rheumatic Diseases
Neuromuscular Diseases