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

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nortriptyline Oral Capsule
Benztropine Oral Product
CBT
Disease MGT
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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a history of a myocardial infarction within the past 3 months Current treatment with an antidepressant which cannot be withdrawn Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine),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)

Sites / Locations

  • University of Maryland, Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Nortriptyline Oral Capsule/CBT

Benztropine Oral Product/CBT

Nortriptyline Oral Capsule/Disease MGT

Benztropine Oral Product/Disease MGT

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Worst Pain
0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
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).

Full Information

First Posted
August 7, 2003
Last Updated
July 21, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00066937
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nortriptyline Oral Capsule/CBT
Arm Type
Experimental
Arm Description
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
Arm Title
Benztropine Oral Product/CBT
Arm Type
Experimental
Arm 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.
Arm Title
Nortriptyline Oral Capsule/Disease MGT
Arm Type
Experimental
Arm Description
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
Arm Title
Benztropine Oral Product/Disease MGT
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nortriptyline Oral Capsule
Intervention Description
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
Intervention Name(s)
Benztropine Oral Product
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
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
Intervention Name(s)
Disease MGT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Pain
Description
0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
Time Frame
baseline, post-treatment, 3 months, 6 months
Title
Change in Pain-related Interference
Description
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
Time Frame
baseline, post-treatment, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Worst Pain
Description
0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
Time Frame
baseline, post-treatment, 3 months, 6 months
Title
Mental Health as Assessed by the Short Form 36 Healthy Survey
Description
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).
Time Frame
baseline, post-treatment, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Haythornthwaite, Ph.D
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Dental School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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