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Comparison of Psychological and Pharmacological Treatments for Pain Due to TMD

This study has been completed.

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
Behavioral: cognitive-behavioral treatment
Phase II

MedlinePlus related topics:   Joint Disorders    Temporomandibular Joint Dysfunction   

ChemIDplus related topics:   Nortriptyline    Nortriptyline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 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
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

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

Investigators
Principal Investigator:     Jennifer A Haythornthwaite, Ph.D     University of Maryland, Dental School    
  More Information

Responsible Party:   John Hopkins University ( Jennifer Haythornwaite )
Study ID Numbers:   NIDCR-13906
First Received:   August 7, 2003
Last Updated:   July 15, 2008
ClinicalTrials.gov Identifier:   NCT00066937
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Craniomandibular Disorders
Joint Diseases
Nortriptyline
Pain
Stomatognathic Diseases

Additional relevant MeSH terms:
Mandibular Diseases
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Jaw Diseases
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 18, 2008




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