| August 7, 2003 |
| July 15, 2008 |
| November 2002 |
| June 2008 (final data collection date for primary outcome measure) |
| Pain [ Time Frame: 4-6 months ] [ Designated as safety issue: No ] |
- Pain
- Physical and psychosocial function
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| Complete list of historical versions of study NCT00066937 on ClinicalTrials.gov Archive Site |
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| Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD |
| Pain Management in Temporomandibular Joint Disorders |
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. |
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 |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
| Temporomandibular Joint Disorders |
- Drug: nortriptyline
- Behavioral: cognitive-behavioral treatment
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| Completed |
| 214 |
| July 2008 |
| June 2008 (final data collection date for primary outcome measure) |
Inclusion:
- Age >= 18 and <= 65
- Pain >= 3 months duration due to temporomandibular joint disorder
- Pain due to TMD is primary if other pain conditions present
Exclusion:
- Continuous, chronic painful non-reducing disc displacement of TMJ and patient can't open mouth
- Unstable or acute severe pain from another pain condition
- Patient is pregnant
- Presence of a medical condition that contraindicates nortriptyline: angle-closure glaucoma,symptomatic orthosis
- EKG: first degree heart block or QTc > 450 msec
- Unstable angina or a history of a myocardial infarction within the past 3 months
- Current treatment with an antidepressant which cannot be withdrawn
- Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine), systemic anti-fungal agents (fluconazole), antiarrhythmics (e.g., quinidine), antipsychotics (e.g., haloperidol), and antibiotics (e.g., erythromycin).
- Presence of dementia, psychosis or other disorder of cognition that impairs ability to participate in minimal contact intervention
- Beck Depression Inventory (BDI) score >= 35 OR BDI Item #9 (suicide item) is scored > 1
- Patient has a terminal illness with a life expectancy of less than six months
- History of arthrotomy of temporomandibular joint
- History of allergic reaction to nortriptyline or benztropine
- History of a therapeutic trial with nortriptyline (dose >= 100 mg for at least 3 weeks)
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00066937 |
| Jennifer Haythornwaite, John Hopkins University |
| NIDCR-13906 |
| National Institute of Dental and Craniofacial Research (NIDCR) |
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| Principal Investigator: |
Jennifer A Haythornthwaite, Ph.D |
University of Maryland, Dental School |
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| National Institute of Dental and Craniofacial Research (NIDCR) |
| July 2008 |