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

Pain Management in Temporomandibular Joint Disorders

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00066937
Enrollment
140
Registered
2003-08-08
Start date
2002-11-30
Completion date
2008-07-31
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

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

Interventions

DRUGNortriptyline 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.

DRUGBenztropine 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.

BEHAVIORALCBT

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.

BEHAVIORALDisease 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.

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Average Painbaseline, post-treatment, 3 months, 6 months0 (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 Interferencebaseline, post-treatment, 3 months, 6 monthsMultidimensional 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

MeasureTime frameDescription
Worst Painbaseline, post-treatment, 3 months, 6 months0 (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 Surveybaseline, post-treatment, 3 months, 6 monthsThe 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Nortriptyline Oral Capsule/CBT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
41
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.
38
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.
37
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.
24
Total140

Baseline characteristics

CharacteristicNortriptyline Oral Capsule/CBTBenztropine Oral Product/CBTNortriptyline Oral Capsule/Disease MGTBenztropine Oral Product/Disease MGTTotal
Age, Continuous35.7 years
STANDARD_DEVIATION 12
38.4 years
STANDARD_DEVIATION 12.5
37.2 years
STANDARD_DEVIATION 11.5
33.3 years
STANDARD_DEVIATION 11.3
36.4 years
STANDARD_DEVIATION 11.9
Region of Enrollment
United States
41 participants38 participants37 participants24 participants140 participants
Sex: Female, Male
Female
31 Participants29 Participants28 Participants17 Participants105 Participants
Sex: Female, Male
Male
10 Participants9 Participants9 Participants7 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 380 / 370 / 24
other
Total, other adverse events
32 / 4124 / 3821 / 3715 / 24
serious
Total, serious adverse events
0 / 410 / 380 / 370 / 24

Outcome results

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

Time frame: baseline, post-treatment, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Nortriptyline Oral Capsule/CBTAverage Painpost treatment2.8 units on a scaleStandard Deviation 2.6
Nortriptyline Oral Capsule/CBTAverage Pain3 months2.1 units on a scaleStandard Deviation 1.6
Nortriptyline Oral Capsule/CBTAverage Painbaseline4.7 units on a scaleStandard Deviation 2.2
Nortriptyline Oral Capsule/CBTAverage Pain6 months2.0 units on a scaleStandard Deviation 1.7
Benztropine Oral Product/CBTAverage Painbaseline4.4 units on a scaleStandard Deviation 2.1
Benztropine Oral Product/CBTAverage Painpost treatment2.7 units on a scaleStandard Deviation 2.1
Benztropine Oral Product/CBTAverage Pain6 months2.0 units on a scaleStandard Deviation 2.1
Benztropine Oral Product/CBTAverage Pain3 months2.4 units on a scaleStandard Deviation 2.2
Nortriptyline Oral Capsule/Disease MGTAverage Painbaseline4.5 units on a scaleStandard Deviation 2.2
Nortriptyline Oral Capsule/Disease MGTAverage Pain3 months2.2 units on a scaleStandard Deviation 2.1
Nortriptyline Oral Capsule/Disease MGTAverage Pain6 months1.4 units on a scaleStandard Deviation 1.6
Nortriptyline Oral Capsule/Disease MGTAverage Painpost treatment2.0 units on a scaleStandard Deviation 1.4
Benztropine Oral Product/Disease MGTAverage Pain6 months2.2 units on a scaleStandard Deviation 2.5
Benztropine Oral Product/Disease MGTAverage Painpost treatment2.8 units on a scaleStandard Deviation 2.1
Benztropine Oral Product/Disease MGTAverage Pain3 months2.5 units on a scaleStandard Deviation 2.1
Benztropine Oral Product/Disease MGTAverage Painbaseline5.0 units on a scaleStandard Deviation 1.8
p-value: <0.05ANOVA
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

Time frame: baseline, post-treatment, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Nortriptyline Oral Capsule/CBTChange in Pain-related InterferenceChange in score from baseline to post-treatment0.9 Change in scores on a scaleStandard Deviation 0.9
Nortriptyline Oral Capsule/CBTChange in Pain-related InterferenceChange in score from baseline to 6 months0.8 Change in scores on a scaleStandard Deviation 0.8
Nortriptyline Oral Capsule/CBTChange in Pain-related InterferenceChange in score from baseline to 3 months0.8 Change in scores on a scaleStandard Deviation 0.9
Benztropine Oral Product/CBTChange in Pain-related InterferenceChange in score from baseline to post-treatment0.5 Change in scores on a scaleStandard Deviation 0.9
Benztropine Oral Product/CBTChange in Pain-related InterferenceChange in score from baseline to 6 months0.7 Change in scores on a scaleStandard Deviation 1.2
Benztropine Oral Product/CBTChange in Pain-related InterferenceChange in score from baseline to 3 months0.8 Change in scores on a scaleStandard Deviation 0.9
Nortriptyline Oral Capsule/Disease MGTChange in Pain-related InterferenceChange in score from baseline to 3 months1.0 Change in scores on a scaleStandard Deviation 0.9
Nortriptyline Oral Capsule/Disease MGTChange in Pain-related InterferenceChange in score from baseline to post-treatment0.5 Change in scores on a scaleStandard Deviation 0.7
Nortriptyline Oral Capsule/Disease MGTChange in Pain-related InterferenceChange in score from baseline to 6 months0.7 Change in scores on a scaleStandard Deviation 0.8
Benztropine Oral Product/Disease MGTChange in Pain-related InterferenceChange in score from baseline to post-treatment1.0 Change in scores on a scaleStandard Deviation 0.9
Benztropine Oral Product/Disease MGTChange in Pain-related InterferenceChange in score from baseline to 6 months0.8 Change in scores on a scaleStandard Deviation 1.1
Benztropine Oral Product/Disease MGTChange in Pain-related InterferenceChange in score from baseline to 3 months1.1 Change in scores on a scaleStandard Deviation 1.2
p-value: <0.05ANOVA
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).

Time frame: baseline, post-treatment, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Nortriptyline Oral Capsule/CBTMental Health as Assessed by the Short Form 36 Healthy Surveybaseline50.5 units on a scaleStandard Deviation 8.1
Nortriptyline Oral Capsule/CBTMental Health as Assessed by the Short Form 36 Healthy Surveypost-treatment50.8 units on a scaleStandard Deviation 10.4
Nortriptyline Oral Capsule/CBTMental Health as Assessed by the Short Form 36 Healthy Survey3 months51.5 units on a scaleStandard Deviation 8.9
Nortriptyline Oral Capsule/CBTMental Health as Assessed by the Short Form 36 Healthy Survey6 months52.2 units on a scaleStandard Deviation 7.8
Benztropine Oral Product/CBTMental Health as Assessed by the Short Form 36 Healthy Surveypost-treatment48.4 units on a scaleStandard Deviation 8.1
Benztropine Oral Product/CBTMental Health as Assessed by the Short Form 36 Healthy Survey3 months50.2 units on a scaleStandard Deviation 8.7
Benztropine Oral Product/CBTMental Health as Assessed by the Short Form 36 Healthy Survey6 months53.3 units on a scaleStandard Deviation 12.8
Benztropine Oral Product/CBTMental Health as Assessed by the Short Form 36 Healthy Surveybaseline49.2 units on a scaleStandard Deviation 9.3
Nortriptyline Oral Capsule/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Survey3 months52.6 units on a scaleStandard Deviation 10
Nortriptyline Oral Capsule/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Surveypost-treatment52.6 units on a scaleStandard Deviation 10
Nortriptyline Oral Capsule/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Survey6 months52.3 units on a scaleStandard Deviation 7.2
Nortriptyline Oral Capsule/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Surveybaseline51.2 units on a scaleStandard Deviation 8.8
Benztropine Oral Product/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Survey6 months53.6 units on a scaleStandard Deviation 7.3
Benztropine Oral Product/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Surveypost-treatment53.3 units on a scaleStandard Deviation 10.6
Benztropine Oral Product/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Surveybaseline48.0 units on a scaleStandard Deviation 8.9
Benztropine Oral Product/Disease MGTMental Health as Assessed by the Short Form 36 Healthy Survey3 months53.8 units on a scaleStandard Deviation 10.1
p-value: <0.05ANOVA
Secondary

Worst Pain

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

ArmMeasureGroupValue (MEAN)Dispersion
Nortriptyline Oral Capsule/CBTWorst Pain3 months3.6 units on a scaleStandard Deviation 2.4
Nortriptyline Oral Capsule/CBTWorst Pain6 months3.3 units on a scaleStandard Deviation 2.1
Nortriptyline Oral Capsule/CBTWorst Painpost-treatment4.0 units on a scaleStandard Deviation 2.9
Nortriptyline Oral Capsule/CBTWorst Painbaseline6.7 units on a scaleStandard Deviation 2.3
Benztropine Oral Product/CBTWorst Painpost-treatment4.1 units on a scaleStandard Deviation 2.8
Benztropine Oral Product/CBTWorst Painbaseline6.1 units on a scaleStandard Deviation 2.2
Benztropine Oral Product/CBTWorst Pain3 months3.3 units on a scaleStandard Deviation 2.3
Benztropine Oral Product/CBTWorst Pain6 months3.1 units on a scaleStandard Deviation 2.7
Nortriptyline Oral Capsule/Disease MGTWorst Pain6 months2.7 units on a scaleStandard Deviation 2.2
Nortriptyline Oral Capsule/Disease MGTWorst Painbaseline6.3 units on a scaleStandard Deviation 2.4
Nortriptyline Oral Capsule/Disease MGTWorst Painpost-treatment3.2 units on a scaleStandard Deviation 2.1
Nortriptyline Oral Capsule/Disease MGTWorst Pain3 months3.4 units on a scaleStandard Deviation 2.7
Benztropine Oral Product/Disease MGTWorst Pain3 months4.1 units on a scaleStandard Deviation 2.9
Benztropine Oral Product/Disease MGTWorst Painpost-treatment4.4 units on a scaleStandard Deviation 2.6
Benztropine Oral Product/Disease MGTWorst Painbaseline7.2 units on a scaleStandard Deviation 1.9
Benztropine Oral Product/Disease MGTWorst Pain6 months3.4 units on a scaleStandard Deviation 2.9
p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026