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

NCT ID: NCT00066937

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2008-07-31

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

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nortriptyline Oral Capsule/CBT

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

Group Type: EXPERIMENTAL

Nortriptyline Oral Capsule

Intervention Type: DRUG

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.

CBT

Intervention Type: BEHAVIORAL

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.

Benztropine Oral Product/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.

Group Type: EXPERIMENTAL

Benztropine Oral Product

Intervention Type: DRUG

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.

CBT

Intervention Type: BEHAVIORAL

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.

Nortriptyline Oral Capsule/Disease MGT

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

Group Type: EXPERIMENTAL

Nortriptyline Oral Capsule

Intervention Type: DRUG

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.

Disease MGT

Intervention Type: BEHAVIORAL

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.

Benztropine Oral Product/Disease MGT

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.

Group Type: ACTIVE_COMPARATOR

Benztropine Oral Product

Intervention Type: DRUG

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.

Disease MGT

Intervention Type: BEHAVIORAL

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.

Interventions

Nortriptyline Oral Capsule

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.

Intervention Type: DRUG

Benztropine Oral Product

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.

Intervention Type: DRUG

CBT

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.

Intervention Type: BEHAVIORAL

Disease MGT

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer A Haythornthwaite, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University of Maryland, Dental School

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01DE013906

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RPN 00-03-21-02

Identifier Type: -

Identifier Source: org_study_id