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| ID | Type | Description | Link |
|---|---|---|---|
| R01DE013906 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nortriptyline Oral Capsule/CBT | Experimental | Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. |
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| Benztropine Oral Product/CBT | Experimental | 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. |
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| Nortriptyline Oral Capsule/Disease MGT | Experimental | Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management. |
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| Benztropine Oral Product/Disease MGT | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nortriptyline Oral Capsule | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Pain | 0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain | baseline, post-treatment, 3 months, 6 months |
| Change in Pain-related Interference | 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 | baseline, post-treatment, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Pain | 0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week | baseline, post-treatment, 3 months, 6 months |
| Mental Health as Assessed by the Short Form 36 Healthy Survey |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Haythornthwaite, Ph.D | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Dental School | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nortriptyline Oral Capsule/CBT | Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. |
| FG001 | Benztropine Oral Product/CBT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| Benztropine Oral Product | Drug | 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. |
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| CBT | Behavioral | 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. |
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| Disease MGT | Behavioral | 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. |
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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).
| baseline, post-treatment, 3 months, 6 months |
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.
| FG002 | 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. |
| FG003 | 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. |
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| NOT COMPLETED |
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| 3 Month Follow-up |
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| 6 Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nortriptyline Oral Capsule/CBT | Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Average Pain | 0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain | Posted | Mean | Standard Deviation | units on a scale | baseline, post-treatment, 3 months, 6 months |
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| Primary | Change in Pain-related Interference | 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 | Posted | Mean | Standard Deviation | Change in scores on a scale | baseline, post-treatment, 3 months, 6 months |
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| Secondary | Worst Pain | 0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week | Posted | Mean | Standard Deviation | units on a scale | baseline, post-treatment, 3 months, 6 months |
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| Secondary | Mental Health as Assessed by the Short Form 36 Healthy Survey | 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). | Posted | Mean | Standard Deviation | units on a scale | baseline, post-treatment, 3 months, 6 months |
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Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nortriptyline Oral Capsule/CBT | Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. | 0 | 41 | 0 | 41 | 32 | 41 |
| EG001 | 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. | 0 | 38 | 0 | 38 | 24 | 38 |
| EG002 | 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. | 0 | 37 | 0 | 37 | 21 | 37 |
| EG003 | 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. | 0 | 24 | 0 | 24 | 15 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drymouth | General disorders | Systematic Assessment |
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| sedation | Nervous system disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Haythornthwaite | Johns Hopkins University | 410-550-7985 | jhaytho1@jhmi.edu |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| post treatment |
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| 3 months |
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| 6 months |
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| OG003 | 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. |
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