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| Descriptive Information Fields | |||||
| Brief Title † | Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD | ||||
| Official Title † | Pain Management in Temporomandibular Joint Disorders | ||||
| Brief Summary | 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. |
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| Detailed Description | 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 |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Pain [ Time Frame: 4-6 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Temporomandibular Joint Disorders | ||||
| Intervention † | Drug: nortriptyline Behavioral: cognitive-behavioral treatment |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 214 | ||||
| Start Date † | November 2002 | ||||
| Completion Date | July 2008 | ||||
| Eligibility Criteria † | Inclusion:
Exclusion:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00066937 | ||||
| Organization ID | NIDCR-13906 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute of Dental and Craniofacial Research (NIDCR) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | August 7, 2003 | ||||
| Last Updated Date | July 15, 2008 | ||||