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.

Condition	Treatment or Intervention	Phase
Temporomandibular Joint Disorders	Drug: nortriptyline  Behavior: cognitive-behavioral treatment	Phase II

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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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• Current treatment with an antidepressant which cannot be withdrawn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)

Maryland
      University of Maryland, Dental School, Baltimore,  Maryland,  21201,  United States; Recruiting

Study ID Numbers:  NIDCR-13906
Record last reviewed:  September 2004
Record first received:  August 7, 2003
ClinicalTrials.gov Identifier:  NCT00066937
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08