Phase 2
N=140
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Temporomandibular Joint Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00066937 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Average Pain — 4.7; 4.4; 4.5; 5.0 units on a scale — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nortriptyline Oral Capsule (Drug); Benztropine Oral Product (Drug); CBT (Behavioral); Disease MGT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain |
4.7; 4.4; 4.5; 5.0; 2.8; 2.7 | <.05 sig |
| PRIMARY Change in Pain-related Interference |
0.9; 0.5; 0.5; 1.0; 0.8; 0.8 | <.05 sig |
| SECONDARY Worst Pain |
6.7; 6.1; 6.3; 7.2; 4.0; 4.1 | <.05 sig |
| SECONDARY Mental Health as Assessed by the Short Form 36 Healthy Survey |
50.5; 49.2; 51.2; 48.0; 50.8; 48.4 | <.05 sig |
Summary
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.
Eligibility Criteria
Inclusion:
- Age >= 18 and = 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- Current treatment with an antidepressant which cannot be withdrawn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)
Data sourced from ClinicalTrials.gov (NCT00066937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.