Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
This study has been completed.
Sponsor:
Johns Hopkins University
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
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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:
Detailed Description:
-
Drug: nortriptyline
Effect of nortriptyline
Behavioral: cognitive-behavioral treatment
Study cognitive-behavioral treatment
Drug: Nortriptyline
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) |
| 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
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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
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 |
| Study First Received: | August 7, 2003 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
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 September 27, 2016