ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00066937
Recruitment Status : Completed
First Posted : August 8, 2003
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Temporomandibular Joint Disorders
Interventions Drug: Nortriptyline Oral Capsule
Drug: Benztropine Oral Product
Behavioral: CBT
Behavioral: Disease MGT
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
Period Title: Treatment Phase
Started 41 38 37 24
Completed 38 33 26 19
Not Completed 3 5 11 5
Period Title: 3 Month Follow-up
Started 38 33 26 19
Completed 33 32 25 15
Not Completed 5 1 1 4
Period Title: 6 Month Follow-up
Started 33 32 25 15
Completed 26 29 22 14
Not Completed 7 3 3 1
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 41 38 37 24 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 38 participants 37 participants 24 participants 140 participants
35.7  (12.0) 38.4  (12.5) 37.2  (11.5) 33.3  (11.3) 36.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 37 participants 24 participants 140 participants
Female
31
  75.6%
29
  76.3%
28
  75.7%
17
  70.8%
105
  75.0%
Male
10
  24.4%
9
  23.7%
9
  24.3%
7
  29.2%
35
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 38 participants 37 participants 24 participants 140 participants
41 38 37 24 140
1.Primary Outcome
Title Average Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 33 26 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 4.7  (2.2) 4.4  (2.1) 4.5  (2.2) 5.0  (1.8)
post treatment 2.8  (2.6) 2.7  (2.1) 2.0  (1.4) 2.8  (2.1)
3 months 2.1  (1.6) 2.4  (2.2) 2.2  (2.1) 2.5  (2.1)
6 months 2.0  (1.7) 2.0  (2.1) 1.4  (1.6) 2.2  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nortriptyline Oral Capsule/CBT, Benztropine Oral Product/CBT, Nortriptyline Oral Capsule/Disease MGT, Benztropine Oral Product/Disease MGT
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVAs compared baseline to each timepoint
2.Primary Outcome
Title Change in Pain-related Interference
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 33 26 19
Mean (Standard Deviation)
Unit of Measure: Change in scores on a scale
Change in score from baseline to post-treatment 0.9  (0.9) 0.5  (0.9) 0.5  (0.7) 1.0  (0.9)
Change in score from baseline to 3 months 0.8  (0.9) 0.8  (0.9) 1.0  (0.9) 1.1  (1.2)
Change in score from baseline to 6 months 0.8  (0.8) 0.7  (1.2) 0.7  (0.8) 0.8  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nortriptyline Oral Capsule/CBT, Benztropine Oral Product/CBT, Nortriptyline Oral Capsule/Disease MGT, Benztropine Oral Product/Disease MGT
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
3.Secondary Outcome
Title Worst Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 33 26 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 6.7  (2.3) 6.1  (2.2) 6.3  (2.4) 7.2  (1.9)
post-treatment 4.0  (2.9) 4.1  (2.8) 3.2  (2.1) 4.4  (2.6)
3 months 3.6  (2.4) 3.3  (2.3) 3.4  (2.7) 4.1  (2.9)
6 months 3.3  (2.1) 3.1  (2.7) 2.7  (2.2) 3.4  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nortriptyline Oral Capsule/CBT, Benztropine Oral Product/CBT, Nortriptyline Oral Capsule/Disease MGT, Benztropine Oral Product/Disease MGT
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
4.Secondary Outcome
Title Mental Health as Assessed by the Short Form 36 Healthy Survey
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 33 26 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 50.5  (8.1) 49.2  (9.3) 51.2  (8.8) 48.0  (8.9)
post-treatment 50.8  (10.4) 48.4  (8.1) 52.6  (10.0) 53.3  (10.6)
3 months 51.5  (8.9) 50.2  (8.7) 52.6  (10.0) 53.8  (10.1)
6 months 52.2  (7.8) 53.3  (12.8) 52.3  (7.2) 53.6  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nortriptyline Oral Capsule/CBT, Benztropine Oral Product/CBT, Nortriptyline Oral Capsule/Disease MGT, Benztropine Oral Product/Disease MGT
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
Time Frame Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Hide Arm/Group 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.
All-Cause Mortality
Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%)   0/37 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%)   0/37 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Nortriptyline Oral Capsule/CBT Benztropine Oral Product/CBT Nortriptyline Oral Capsule/Disease MGT Benztropine Oral Product/Disease MGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/41 (78.05%)   24/38 (63.16%)   21/37 (56.76%)   15/24 (62.50%) 
Gastrointestinal disorders         
constipation   10/41 (24.39%)  7/38 (18.42%)  9/37 (24.32%)  4/24 (16.67%) 
General disorders         
drymouth   20/41 (48.78%)  14/38 (36.84%)  13/37 (35.14%)  9/24 (37.50%) 
Nervous system disorders         
sedation   7/41 (17.07%)  8/38 (21.05%)  7/37 (18.92%)  3/24 (12.50%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer Haythornthwaite
Organization: Johns Hopkins University
Phone: 410-550-7985
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00066937     History of Changes
Other Study ID Numbers: RPN 00-03-21-02
R01DE013906 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2003
First Posted: August 8, 2003
Results First Submitted: April 17, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017