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

Pain Management in Temporomandibular Joint Disorders

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Drug: Nortriptyline Oral Capsule; Behavioral: CBT; Drug: Benztropine Oral Product; Behavioral: Disease MGT

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Current treatment with an antidepressant which cannot be withdrawn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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nortriptyline Oral Capsule/CBT; Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.	Drug: 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.; Behavioral: 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.
EXPERIMENTAL: 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.	Behavioral: 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.; 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.
EXPERIMENTAL: 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.	Drug: 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.; 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.
ACTIVE_COMPARATOR: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain	0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain	baseline, post-treatment, 3 months, 6 months
Change in Pain-related Interference	Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference	baseline, post-treatment, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Pain	0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week	baseline, post-treatment, 3 months, 6 months
Mental Health as Assessed by the Short Form 36 Healthy Survey	The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).	baseline, post-treatment, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Jennifer A Haythornthwaite, Ph.D, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: August 7, 2003
• First Submitted That Met QC Criteria: August 7, 2003
• First Posted (ESTIMATE): August 8, 2003

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Antidepressive Agents, Tricyclic; Dopamine Uptake Inhibitors; Adrenergic Uptake Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Nortriptyline; Benztropine
• Other Study ID Numbers: RPN 00-03-21-02; R01DE013906 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No