Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Intervention: Nortriptyline Oral Capsule; Benztropine Oral Product; CBT; Disease MGT
Intervention description: Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.; 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.; Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.; Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
Intervention MeSH terms: Benztropine; Nortriptyline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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)