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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Dental and Craniofacial Research (NIDCR)

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00066937

First received: August 7, 2003

Last updated: June 25, 2010

Last verified: July 2008

History of Changes

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 Intervention Model: Factorial Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pain Management in Temporomandibular Joint Disorders

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Temporomandibular Joint Dysfunction

Drug Information available for: Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Pain [ Time Frame: 4-6 months ]


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:

Effect of nortriptyline

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 (Adult)
Sexes Eligible for Study:	All
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

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators


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

More Information


Responsible Party:	Jennifer Haythornthwaite, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00066937 History of Changes
Other Study ID Numbers:	NIDCR-13906 R01DE013906 ( US NIH Grant/Contract Award Number )
Study First Received:	August 7, 2003
Last Updated:	June 25, 2010

Additional relevant MeSH terms:


Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Disease Joint Diseases 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 Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017

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