Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00066937 |
Recruitment Status
:
Completed
First Posted
: August 8, 2003
Results First Posted
: July 24, 2017
Last Update Posted
: July 24, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Temporomandibular Joint Disorders | Drug: Nortriptyline Oral Capsule Drug: Benztropine Oral Product Behavioral: CBT Behavioral: Disease MGT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pain Management in Temporomandibular Joint Disorders |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | July 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Nortriptyline Oral Capsule/CBT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
|
Drug: Nortriptyline Oral Capsule
Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.
Behavioral: CBT
Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.
|
Experimental: Benztropine Oral Product/CBT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
|
Drug: Benztropine Oral Product
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.
Behavioral: CBT
Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.
|
Experimental: Nortriptyline Oral Capsule/Disease MGT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
|
Drug: Nortriptyline Oral Capsule
Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.
Behavioral: Disease MGT
Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
|
Active Comparator: Benztropine Oral Product/Disease MGT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
|
Drug: Benztropine Oral Product
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.
Behavioral: Disease MGT
Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
|
- Average Pain [ Time Frame: baseline, post-treatment, 3 months, 6 months ]0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
- Change in Pain-related Interference [ Time Frame: baseline, post-treatment, 3 months, 6 months ]Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference
- Worst Pain [ Time Frame: baseline, post-treatment, 3 months, 6 months ]0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
- Mental Health as Assessed by the Short Form 36 Healthy Survey [ Time Frame: baseline, post-treatment, 3 months, 6 months ]The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066937
United States, Maryland | |
University of Maryland, Dental School | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Jennifer A Haythornthwaite, Ph.D | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00066937 History of Changes |
Other Study ID Numbers: |
RPN 00-03-21-02 R01DE013906 ( U.S. NIH Grant/Contract ) |
First Posted: | August 8, 2003 Key Record Dates |
Results First Posted: | July 24, 2017 |
Last Update Posted: | July 24, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
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 Benztropine 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 Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists |