Biobehavioral Pain Management in TMD

Completed · Not applicable

Conditions studied: Temporomandibular Joint Disorder

In brief

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-related co-morbidities. Pain-related catastrophizing (CAT) and sleep continuity disturbance (SCD) are well established modifiable risk factors for TMD and other idiopathic pain conditions. Neither the causal status nor the neurobiological mechanisms by which these factors exert their effects on clinical pain have been established. We propose that CAT and SCD influence clinical pain through shared alterations in pain modulation and key neurobiological pathways, including amplified inflammatory activity, autonomic activity, and adrenocortical functioning. Beyond these shared mechanisms, however, we propose to determine whether pre-sleep CAT increases cortical arousal during sleep. The cognitive dimensions of pre-sleep arousal, particularly rumination and negative sleep-related thoughts, are central to the phenomenology of insomnia. Extending this notion, we propose that CAT in those experiencing ongoing clinical pain fosters sleep disturbance owing to increased pre- and peri-sleep cognitive arousal. Moreover, we propose that pre-sleep CAT is related to subtle variations in objective indices of fragmented sleep (e.g., cortical arousal). We will examine key hypotheses derived from this framework using a brief, prospective randomized experiment, which will permit careful analysis of the temporal patterning of how changes in either CAT or SCD influence each other and contribute to alterations in pain modulatory systems, key nociceptive mechanisms, and clinical pain. Women experiencing at least moderate chronic TMD pain (N=225) who demonstrate at least mild trait catastrophizing and meet at least subclinical insomnia criteria (SCD) will be randomly assigned to: 1) cognitive therapy for catastrophizing (CT-CAT); 2) behavior therapy for sleep disturbance (BT-SCD); or 3) TMD education (Control). Assessments of clinical pain, sleep disturbance, catastrophizing, pain sensitivity and modulatory systems, and indices of inflammatory activity, adrenocortical function and autonomic balance will be completed at baseline, 4 weeks (mid-manipulation) and 8 weeks (post-manipulation). Clinical pain, sleep, catastrophizing and covariates will additionally be measured at 16 weeks (follow-up).

Key facts

Study ID

NCT01794624

Run by

Johns Hopkins University

People needed

300

Starts

2013-04-01

Expected to finish

2018-06-01

Last updated by the study team

2018-07-19

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Maryland Dental School: Brotman Facial Pain Clinic — Baltimore, Maryland, United States
• Johns Hopkins Bayview Meidical Center: Behavioral Medicine Research Laboratory — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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