Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
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 |
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 |
Estimated Enrollment: | 116 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | May 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 |
Principal Investigator: | Mark D Litt, Ph.D. | University of Connecticut Health Center |
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 |
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 |
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 |