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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00066937
First received: August 7, 2003
Last updated: June 25, 2010
Last verified: July 2008
  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
Behavioral: cognitive-behavioral treatment
Drug: Nortriptyline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Management in Temporomandibular Joint Disorders

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Pain [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: November 2002
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: nortriptyline
    Effect of nortriptyline
    Behavioral: cognitive-behavioral treatment
    Study cognitive-behavioral treatment
    Drug: Nortriptyline
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066937

Locations
United States, Maryland
University of Maryland, Dental School
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jennifer A Haythornthwaite, Ph.D University of Maryland, Dental School
  More Information

No publications provided

Responsible Party: Jennifer Haythornthwaite, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00066937     History of Changes
Other Study ID Numbers: NIDCR-13906, R01DE013906
Study First Received: August 7, 2003
Last Updated: June 25, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Nortriptyline
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014