Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Benztropine; Nortriptyline

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• Current treatment with an antidepressant which cannot be withdrawn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)