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

Phase 2

Completed

Conditions: Temporomandibular Joint Disorders

Interventions: Drug: Benztropine Oral Product
Drug: Nortriptyline Oral Capsule
Behavioral: CBT
Behavioral: Disease MGT

Registration Number: NCT00066937

Lead Sponsor: Johns Hopkins University

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nortriptyline Oral Capsule/CBT	CBT	Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
Benztropine Oral Product/Disease MGT	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. Study participants also receive 6 sessions of TMD disease management.
Benztropine Oral Product/CBT	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. Study participants also receive 6 sessions of CBT.
Benztropine Oral Product/CBT	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 Oral Capsule/Disease MGT	Disease MGT	Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
Benztropine Oral Product/Disease MGT	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.
Nortriptyline Oral Capsule/Disease MGT	Nortriptyline Oral Capsule	Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
Nortriptyline Oral Capsule/CBT	Nortriptyline Oral Capsule	Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.

Primary Outcome Measures

Name	Time	Method
Average Pain	baseline, post-treatment, 3 months, 6 months	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	baseline, post-treatment, 3 months, 6 months	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

Name	Time	Method
Worst Pain	baseline, post-treatment, 3 months, 6 months	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	baseline, post-treatment, 3 months, 6 months	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).