Status:
COMPLETED
Biobehavioral Pain Management in TMD
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
University of Maryland
Conditions:
Temporomandibular Joint Disorder
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
TMD is a poorly understood chronic pain disorder that affects up to 15% of the adult population, notably impacting women, is linked to greater healthcare utilization, and associated with multiple pain...
Detailed Description
Temporomandibular Joint Disorder (TMJD) is a poorly understood chronic pain disorder characterized by pain and dysfunction in the jaw joint and the muscles that control jaw movement. TMJD affects up t...
Eligibility Criteria
Inclusion
- Provides a signed and dated informed consent form
- Is a female between 18 and 60 years of age
- Meets Research Diagnostic Criteria/ Temporomandibular Joint Disorders (RDC-TJMD)Axis I TMJD diagnosis at Visit 1
- Reports facial pain present for \> 3 months
- Reports facial pain present on \> 10 days of the last 30 days
- At Visit 1 (Screening visit), reports an average pain severity score over the past week of ≥3 on a numerical rating scale (0-10)
- Reports trouble initiating and/or maintaining sleep regularly (\> 3 days/week) for at least 1 month
- Scores \> 8 on the Insomnia Severity Scale at Visit 2
- Scores \> 8 on the Pain Catastrophizing Scale at Visit 2
- If using non-opioid medication for pain treatment:
- Has been on the same treatment regimen for the last 30 days prior to Visit 1
- Is willing to stay on the same treatment regimen for the duration of the study, with the addition of rescue medications (as needed use of opioid \< 3x/week, non-steroidal anti-inflammatory, acetaminophen, or aspirin). Use of rescue medications is restricted to use only more than 24 hours prior to QST.
- If using an opioid for pain treatment or a benzodiazepine/benzodiazepine receptor agonist or sedating tricyclic antidepressant (e.g., trazodone, amitriptyline, doxepin) for sleep \> 3 days/week, is willing to undergo a 4-week washout period prior to enrolling in the study.
- If of child-bearing potential, agrees at Visit 2 to use contraception throughout the study.
- If post-menopausal, has been so for at least 12 consecutive months prior to Visit 1
- Is able to understand and willing to comply with all study procedures and is available for the duration of the study
Exclusion
- BMI \> 35 at Visit 2
- Resting systolic blood pressure \> 140 mm Hg and diastolic blood pressure \> 90 mm Hg at Visit 2
- History of any type of TMJ surgery or TMJ growth disturbances, neoplasm, or injury to the TMJ area within the past six months
- Scheduled for surgery for TMJ during study participation period.
- History of major medical disease known to impact sleep, the central nervous system (e.g., chronic obstructive pulmonary disease, seizure disorder, systemic lupus erythematosus, multiple sclerosis, cancer, congestive heart failure), or peripheral neuropathy.
- Diagnosis of Raynaud's Syndrome
- History of unstable major psychiatric disorder
- Active \[within 6 months\] substance or alcohol abuse
- Regular (≥ 3x/week) use of opioids, benzodiazepines/benzodiazepine receptor agonists, or sedating tricyclic antidepressants reported at Visit 1
- Stable preferred sleep phase between 10am and 10pm (i.e., night workers) or self-reported variability in sleep due to changes in work shift (i.e., nurses or emergency workers)
- Score ≥ 27 on Center for Epidemiologic Studies of Depression Scale (CES-D) or self-reported suicidal ideation
- Positive urine toxicology screening test (barbiturates, marijuana, alcohol, cocaine and other recreational drugs of abuse) at Visit 2
- Positive urine pregnancy test at Visit 2
- Respiratory Disturbance Index (RDI) \> 15 as determined from the Baseline PSG
- Periodic limb movement index with arousals \> 15 as determined from the Baseline PSG
- Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01794624
Start Date
April 1 2013
End Date
June 1 2018
Last Update
July 19 2018
Active Locations (2)
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1
University of Maryland Dental School: Brotman Facial Pain Clinic
Baltimore, Maryland, United States, 21201
2
Johns Hopkins Bayview Meidical Center: Behavioral Medicine Research Laboratory
Baltimore, Maryland, United States, 21224