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Brief Treatment for Temporomandibular Pain
This study is ongoing, but not recruiting participants.
First Received: August 15, 2003   Last Updated: May 24, 2007   History of Changes
Sponsors and Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
University of Connecticut
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00067366
  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 Phase
Temporomandibular Joint Syndrome
Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Orofacial Pain
Behavioral: Cognitive-Behavioral treatment
Phase I
Phase II

MedlinePlus related topics: Fibromyalgia Temporomandibular Joint Dysfunction
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Brief Focused Treatment for TMD: Mechanisms of Action

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Pain
  • Pain-related interference with functioning
  • Depressive symptoms

Estimated Enrollment: 116
Study Start Date: October 2003
Estimated Study Completion Date: May 2007
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067366

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

No publications provided

Study ID Numbers: NIDCR-14607
Study First Received: August 15, 2003
Last Updated: May 24, 2007
ClinicalTrials.gov Identifier: NCT00067366     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Facial Pain
Facies
Fibromyalgia
Myofascial Pain Syndromes
Joint Diseases
Pain
Rheumatic Diseases
Signs and Symptoms
Temporomandibular Joint Disorders
Muscular Diseases
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Neuromuscular Diseases
Craniomandibular Disorders
Neurologic Manifestations
Stomatognathic Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009