Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Temporomandibular Joint Disorders
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders
Eligibility 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a history of a myocardial infarction within the past 3 months Current treatment with an antidepressant which cannot be withdrawn Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine),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)
Sites / Locations
- University of Maryland, Dental School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Nortriptyline Oral Capsule/CBT
Benztropine Oral Product/CBT
Nortriptyline Oral Capsule/Disease MGT
Benztropine Oral Product/Disease MGT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.