Expired Study
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Baltimore, Maryland 21201


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.


Study summary:

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


Criteria:

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history of a myocardial infarction within the past 3 months - Current treatment with an antidepressant which cannot be withdrawn - Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine),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)


NCT ID:

NCT00066937


Primary Contact:

Principal Investigator
Jennifer A Haythornthwaite, Ph.D
Johns Hopkins University


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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