Temporomandibular Joint DisordersPhase 2NCT00066937
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
A Phase 2 study testing Nortriptyline Oral Capsule, Benztropine Oral Product and CBT in people with Temporomandibular Joint Disorders, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Nortriptyline Oral Capsule, Benztropine Oral Product and CBT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 and <= 65
- Pain >= 3 months duration due to temporomandibular joint disorder
- Pain due to TMD is primary if other pain conditions present
Who cannot join
- 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
Show all 14Show fewer
- Current treatment with an antidepressant which cannot be withdrawn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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Dental School
Baltimore, Maryland, 21201
About this study
Official title: Pain Management in Temporomandibular Joint Disorders
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.
Read the 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
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Nortriptyline Oral Capsule, Benztropine Oral Product, CBT, Disease MGT
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nortriptyline Oral CapsuleDrug
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.
Benztropine Oral ProductDrug
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.
CBTBehavioural
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.
Disease MGTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nortriptyline Oral Capsule; Behavioral: CBT |
| 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. Receives: Drug: Benztropine Oral Product; Behavioral: CBT |
| 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. Receives: Drug: Nortriptyline Oral Capsule; Behavioral: Disease MGT |
| 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. Receives: Drug: Benztropine Oral Product; Behavioral: Disease MGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, post-treatment, 3 months, 6 months
Secondary outcomes (2)
Worst Pain
0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week
Measured: baseline, post-treatment, 3 months, 6 months
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).
Measured: baseline, post-treatment, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2003 (estimated)
- Study startNov 2002
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Haythornthwaite, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066937
- Sponsor's protocol ID
- RPN 00-03-21-02
- Other IDs
- R01DE013906
- Status last verified
- Jul 2017
- First submitted
- 7 Aug 2003
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT00066937
- Acronym / sponsor ID
- RPN 00-03-21-02
- Conditions
- Temporomandibular Joint Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Nov 2002
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Aug 2003 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nortriptyline Oral Capsule/CBT | Experimental | Drug: Nortriptyline Oral Capsule, Behavioral: CBTNortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. |
| Benztropine Oral Product/CBT | Experimental | Drug: Benztropine Oral Product, Behavioral: CBTBenztropine 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. |
| Nortriptyline Oral Capsule/Disease MGT | Experimental | Drug: Nortriptyline Oral Capsule, Behavioral: Disease MGTNortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management. |
| Benztropine Oral Product/Disease MGT | Active comparator | Drug: Benztropine Oral Product, Behavioral: Disease MGTBenztropine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 and <= 65
- Pain >= 3 months duration due to temporomandibular joint disorder
- Pain due to TMD is primary if other pain conditions present
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nortriptyline Oral CapsuleNortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile. | Drug | Nortriptyline Oral Capsule/CBT, Nortriptyline Oral Capsule/Disease MGT |
| Benztropine Oral ProductBenztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. | Drug | Benztropine Oral Product/CBT, Benztropine Oral Product/Disease MGT |
| CBTSix 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. | Behavioural | Benztropine Oral Product/CBT, Nortriptyline Oral Capsule/CBT |
| Disease MGTSix 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. | Behavioural | Benztropine Oral Product/Disease MGT, Nortriptyline Oral Capsule/Disease MGT |
Primary outcome
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
2 secondary outcomes
Worst Pain
Time frame: baseline, post-treatment, 3 months, 6 months
Mental Health as Assessed by the Short Form 36 Healthy Survey
Time frame: baseline, post-treatment, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Haythornthwaite, Ph.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nortriptyline Oral Capsule, Benztropine Oral Product and CBT in people with Temporomandibular Joint Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain (time frame: baseline, post-treatment, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.