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

Temporomandibular Joint Disorders Clinical Trial

Official title:

Pain Management in Temporomandibular Joint Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066937
• Other study ID #: RPN 00-03-21-02
• Secondary ID: R01DE013906
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2003
• Last updated: July 21, 2017
• Start date: November 2002
• Est. completion date: July 2008

Study information

• Verified date: July 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• 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:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland, Dental School	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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