Brief Treatment for Temporomandibular Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Litt, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00067366
First received: August 15, 2003
Last updated: September 19, 2011
Last verified: September 2011
  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
Orofacial Pain
Behavioral: Cognitive-Behavioral treatment
Behavioral: Attention and lifestyle counseling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Focused Treatment for TMD: Mechanisms of Action

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Pain [ Time Frame: Every 3 months out to 12 months ] [ Designated as safety issue: No ]
    Multidimensional pain ratings collected in person every 3 months

  • Pain-related interference with functioning [ Time Frame: every 3 months out to 12 months ] [ Designated as safety issue: No ]
    Multidimensional function ratings collected in person every 3 months

  • Depressive symptoms [ Time Frame: Every 3 months out to 12 months ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Health Center
Investigators
Principal Investigator: Mark D Litt, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Mark Litt, Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00067366     History of Changes
Other Study ID Numbers: NIDCR-14607
Study First Received: August 15, 2003
Last Updated: September 19, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 29, 2014