Full Text View
Tabular View
No Study Results Posted
Related Studies
Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD
This study has been completed.
Study NCT00066937   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 7, 2003   Last Updated: July 15, 2008   History of Changes

August 7, 2003
July 15, 2008
November 2002
June 2008   (final data collection date for primary outcome measure)
Pain [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • Pain
  • Physical and psychosocial function
Complete list of historical versions of study NCT00066937 on ClinicalTrials.gov Archive Site
 
 
 
Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD
Pain Management in Temporomandibular Joint Disorders

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.

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

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Temporomandibular Joint Disorders
  • Drug: nortriptyline
  • Behavioral: cognitive-behavioral treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
214
July 2008
June 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066937
Jennifer Haythornwaite, John Hopkins University
NIDCR-13906
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Jennifer A Haythornthwaite, Ph.D University of Maryland, Dental School
National Institute of Dental and Craniofacial Research (NIDCR)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP