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| Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
| Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT00066937 |
Purpose
The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.
| Condition | Intervention | Phase |
|
Temporomandibular Joint Disorders |
Drug: nortriptyline Behavioral: cognitive-behavioral treatment |
Phase II |
| MedlinePlus related topics: | Joint Disorders Temporomandibular Joint Dysfunction |
| ChemIDplus related topics: | Nortriptyline Nortriptyline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Pain Management in Temporomandibular Joint Disorders |
| Estimated Enrollment: | 214 |
| Study Start Date: | November 2002 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| United States, Maryland | |||||
| University of Maryland, Dental School | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| Principal Investigator: | Jennifer A Haythornthwaite, Ph.D | University of Maryland, Dental School |
More Information
| Responsible Party: | John Hopkins University ( Jennifer Haythornwaite ) |
| Study ID Numbers: | NIDCR-13906 |
| First Received: | August 7, 2003 |
| Last Updated: | July 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066937 |
| Health Authority: | United States: Federal Government |
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