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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 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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