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Trial record 3 of 14 for:    Temporomandibular Joint Disorders | NIH

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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.

Participant Flow for 3 periods

Period 1:   Treatment Phase
    Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT
STARTED   41   38   37   24 
COMPLETED   38   33   26   19 
NOT COMPLETED   3   5   11   5 

Period 2:   3 Month Follow-up
    Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT
STARTED   38   33   26   19 
COMPLETED   33   32   25   15 
NOT COMPLETED   5   1   1   4 

Period 3:   6 Month Follow-up
    Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT
STARTED   33   32   25   15 
COMPLETED   26   29   22   14 
NOT COMPLETED   7   3   3   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   38   37   24   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.7  (12.0)   38.4  (12.5)   37.2  (11.5)   33.3  (11.3)   36.4  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   41   38   37   24   140 


  Outcome Measures

1.  Primary:   Average Pain   [ Time Frame: baseline, post-treatment, 3 months, 6 months ]

Measure Type Primary
Measure Title Average Pain
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.

Measured Values
   Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT 
Participants Analyzed   38   33   26   19 
Average Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
       
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) 


Statistical Analysis 1 for Average Pain
Groups [1] All groups
Statistical Test Type [2] Other
Statistical Method [3] ANOVA
P Value [4] <.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVAs compared baseline to each timepoint
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Change in Pain-related Interference   [ Time Frame: baseline, post-treatment, 3 months, 6 months ]

Measure Type Primary
Measure Title Change in Pain-related Interference
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.

Measured Values
   Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT 
Participants Analyzed   38   33   26   19 
Change in Pain-related Interference 
[Units: Change in scores on a scale]
Mean (Standard Deviation)
       
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) 


Statistical Analysis 1 for Change in Pain-related Interference
Groups [1] All groups
Statistical Test Type [2] Other
Statistical Method [3] ANOVA
P Value [4] <.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Worst Pain   [ Time Frame: baseline, post-treatment, 3 months, 6 months ]

Measure Type Secondary
Measure Title Worst Pain
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.

Measured Values
   Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT 
Participants Analyzed   38   33   26   19 
Worst Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
       
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) 


Statistical Analysis 1 for Worst Pain
Groups [1] All groups
Statistical Test Type [2] Other
Statistical Method [3] ANOVA
P Value [4] <.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Mental Health as Assessed by the Short Form 36 Healthy Survey   [ Time Frame: baseline, post-treatment, 3 months, 6 months ]

Measure Type Secondary
Measure Title Mental Health as Assessed by the Short Form 36 Healthy Survey
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nortriptyline Oral Capsule/CBT Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
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.
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.
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.

Measured Values
   Nortriptyline Oral Capsule/CBT   Benztropine Oral Product/CBT   Nortriptyline Oral Capsule/Disease MGT   Benztropine Oral Product/Disease MGT 
Participants Analyzed   38   33   26   19 
Mental Health as Assessed by the Short Form 36 Healthy Survey 
[Units: Units on a scale]
Mean (Standard Deviation)
       
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) 


Statistical Analysis 1 for Mental Health as Assessed by the Short Form 36 Healthy Survey
Groups [1] All groups
Statistical Test Type [2] Other
Statistical Method [3] ANOVA
P Value [4] <.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jhaytho1@jhmi.edu



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