Clinical trial NCT00066937: Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Official title: Pain Management in Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2003-08-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

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* Current treatment with an antidepressant which cannot be withdrawn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)

Primary outcomes:
measure: Average Pain
timeFrame: baseline, post-treatment, 3 months, 6 months
measure: Change in Pain-related Interference
timeFrame: baseline, post-treatment, 3 months, 6 months
Secondary outcomes:
measure: Worst Pain
timeFrame: baseline, post-treatment, 3 months, 6 months
measure: Mental Health as Assessed by the Short Form 36 Healthy Survey
timeFrame: baseline, post-treatment, 3 months, 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Dental School
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jennifer A Haythornthwaite, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: