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| Sponsor: | University of Connecticut Health Center |
|---|---|
| Information provided by (Responsible Party): | Mark Litt, University of Connecticut Health Center |
| 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 Orofacial Pain |
Behavioral: Cognitive-Behavioral treatment Behavioral: Attention and lifestyle counseling |
Phase I Phase II |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
Fibromyalgia Myofascial Pain Syndromes Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Facial Pain Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases |
Nervous System Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Joint Diseases Stomatognathic Diseases Pain Neurologic Manifestations Signs and Symptoms |