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Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD

This study is currently recruiting patients

Verified by National Institute of Dental and Craniofacial Research (NIDCR) September 2006

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00066937


Purpose

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.


Condition Intervention Phase
Temporomandibular Joint Disorders Drug: Nortriptyline
Behavior: cognitive-behavioral treatment
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Official Title: Pain Management in Temporomandibular Joint Disorders

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):
Primary Outcomes: Physical and psychosocial function; Pain
Expected Total Enrollment:  214

Study start: November 2002;  Expected completion: September 2006
Last follow-up: February 2005;  Data entry closure: September 2006

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

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
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)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00066937


Maryland
University of Maryland, Dental School, Baltimore,  Maryland,  21201,  United States; Recruiting
Jennifer A Haythornthwaite, Ph.D  410-614-9850    jhaytho1@jhmi.edu 
Jennifer A Haythornjthwaite, Ph.D.,  Principal Investigator

Study chairs or principal investigators

Jennifer A Haythornthwaite, Ph.D,  Principal Investigator,  University of Maryland, Dental School   

More Information

Study ID Numbers:  NIDCR-13906
Last Updated:  September 14, 2006
Record first received:  August 7, 2003
ClinicalTrials.gov Identifier:  NCT00066937
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-29





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