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Brief Treatment for Temporomandibular Pain
This study is ongoing, but not recruiting participants.
Study NCT00067366   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 15, 2003   Last Updated: May 24, 2007   History of Changes

August 15, 2003
May 24, 2007
October 2003
 
  • Pain
  • Pain-related interference with functioning
  • Depressive symptoms
Same as current
Complete list of historical versions of study NCT00067366 on ClinicalTrials.gov Archive Site
 
 
 
Brief Treatment for Temporomandibular Pain
Brief Focused Treatment for TMD: Mechanisms of Action

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.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Temporomandibular Joint Syndrome
  • Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
  • Orofacial Pain
Behavioral: Cognitive-Behavioral treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
116
May 2007
 

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067366
 
NIDCR-14607
National Institute of Dental and Craniofacial Research (NIDCR)
University of Connecticut
Principal Investigator: Mark D Litt, Ph.D. University of Connecticut Health Center
National Institute of Dental and Craniofacial Research (NIDCR)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP