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

Sponsor:	Johns Hopkins University
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	Johns Hopkins University
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 Drug: Nortriptyline	Phase II

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:

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 ] [ 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:

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
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

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

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:

Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Nortriptyline
Adrenergic Uptake Inhibitors

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012