|
Brief Treatment for Temporomandibular Pain Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Brief Treatment for Temporomandibular Pain conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Brief Treatment for Temporomandibular Pain Clinical research trials and Brief Treatment for Temporomandibular Pain healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Brief Treatment for Temporomandibular Pain. Brief Treatment for Temporomandibular Pain Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Brief Treatment for Temporomandibular Pain clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Brief Treatment for Temporomandibular Pain condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Brief Treatment for Temporomandibular Pain  Brief Treatment for Temporomandibular Pain
Brief Treatment for Temporomandibular Pain
For Condition: Orofacial Pain,Temporomandibular Joint Syndrome,Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) , University of Connecticut
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 116
Location and Contact Information:
University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Mark Litt 860-679-4680
Additional Information:
Study ID Numbers: NIDCR-14607;
Study Start Date: October 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067366
Other Temporomandibular Joint Syndrome Studies:
1. Brief Treatment for Temporomandibular Pain
Related Studies:
Other Temporomandibular Joint Syndrome Clinical Trials
Other Connecticut Clinical Trials
Other Farmington Clinical Trials
Brief Treatment for Temporomandibular Pain
|
|
|
|
|
|
|
|
