ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD

This study has been completed.
Information provided by National Institute of Dental and Craniofacial Research (NIDCR)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD
Official Title  Pain Management in 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

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Primary Outcome Measure  Pain [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Temporomandibular Joint Disorders
Intervention  Drug: nortriptyline
Behavioral: cognitive-behavioral treatment
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  214
Start Date  November 2002
Completion Date July 2008
Eligibility 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)
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00066937
Organization ID NIDCR-13906
Secondary IDs ††
Study Sponsor  National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators ††
Investigators 
Principal Investigator:     Jennifer A Haythornthwaite, Ph.D     University of Maryland, Dental School    
Information Provided By National Institute of Dental and Craniofacial Research (NIDCR)
Verification Date July 2008
First Received Date  August 7, 2003
Last Updated Date July 15, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers