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Brief Treatment for Temporomandibular Pain

This study is currently recruiting patients

Verified by National Institute of Dental and Craniofacial Research (NIDCR) September 2006

Sponsored by: 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
Behavior:
Cognitive-Behavioral treatment
Phase I
Phase II

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 Outcomes: Pain; Pain-related interference with functioning; Depressive symptoms
Expected Total Enrollment:  116

Study start: October 2003;  Expected completion: March 2008
Last follow-up: December 2006;  Data entry closure: February 2007

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   -   65 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00067366


Connecticut
University of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States; Recruiting
Mark D Litt, Ph.D.  860-679-4680    Litt@nso.uchc.edu 
Mark D Litt, Ph.D.,  Principal Investigator

Study chairs or principal investigators

Mark D Litt, Ph.D.,  Principal Investigator,  University of Connecticut   

More Information

Study ID Numbers:  NIDCR-14607
Last Updated:  September 14, 2006
Record first received:  August 15, 2003
ClinicalTrials.gov Identifier:  NCT00067366
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-29





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