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

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Temporomandibular Joint Disorders

Treatments: Behavioral: CBT; Drug: Benztropine Oral Product; Behavioral: Disease MGT; Drug: Nortriptyline Oral Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00066937

R01DE013906 (U.S. NIH Grant/Contract)

RPN 00-03-21-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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• Current treatment with an antidepressant which cannot be withdrawn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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups

Nortriptyline Oral Capsule/CBT

Experimental group

Description:

Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.

Treatment:

Drug: Nortriptyline Oral Capsule

Behavioral: CBT

Benztropine Oral Product/CBT

Experimental group

Description:

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.

Treatment:

Drug: Benztropine Oral Product

Behavioral: CBT

Nortriptyline Oral Capsule/Disease MGT

Experimental group

Description:

Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.

Treatment:

Drug: Nortriptyline Oral Capsule

Behavioral: Disease MGT

Benztropine Oral Product/Disease MGT

Active Comparator group

Description:

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.

Treatment:

Drug: Benztropine Oral Product

Behavioral: Disease MGT