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Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain

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ClinicalTrials.gov Identifier: NCT02630771
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls.

Condition or disease Intervention/treatment
Toothache Temporomandibular Joint Disorders Procedure: Pressure pain threshold

Detailed Description:

Chronic orofacial pain disorders may present localized in the mouth such as with persistent dentoalveolar pain disorder (PDAP) or widespread in the head/face/jaw such as with temporomandibular disorders (TMD). PDAP pain manifests in a tooth that usually underwent root canal treatment or in the site formally occupied by such tooth, while TMD pain is usually reported over the preauricular area, jaws and temples. These commonly comorbid disorders have a significant impact on the individual and society. Their mechanisms are poorly understood with evidence suggesting deficient pain modulation and abnormal brain features. PDAP and TMD patients, when compared to controls, have abnormal sensory/pain processing as well as brain structural and functional differences.

This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in PDAP patients with and without TMD. All measures from patients will be compared to painfree controls. This knowledge will support better understanding of mechanisms involved in PDAP and will support development of mechanistic-based clinical treatments for the patients the investigators serve. Findings from these investigations will likely contribute to our understanding of other chronic pain conditions.


Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PDAP only
Persistent dentoalveolar pain disorder patients who do not fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation.
Procedure: Pressure pain threshold
Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
Other Name: PPT

PDAP + TMD
Persistent dentoalveolar pain disorder patients who also fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation.
Procedure: Pressure pain threshold
Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
Other Name: PPT

Painfree controls
Painfree subjects. Pressure pain threshold before/during conditioned pain modulation.
Procedure: Pressure pain threshold
Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
Other Name: PPT




Primary Outcome Measures :
  1. Pressure pain threshold change before and during conditioned pain modulation [ Time Frame: Baseline ]
    Pressure pain thresholds will be determined over the skin overlaying the masseter muscles bilaterally and over the right thenar eminence using a pressure algometer before and during the application of a concurrent noxious heat stimulus to the left forearm.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females with age range 18-65 years
Criteria

Inclusion Criteria:

  1. Age- and handedness-matched painfree controls using frequency matching to maintain similar group averages:

    • No self-report of persistent pain conditions for the last 6 months;
    • No diagnosis of PDAP or TMD;
  2. PDAP only:

    • Fulfilling diagnostic criteria per Nixdorf et al., 20122
    • Characteristic dentoalveolar PDAP pain cannot be increased by pressure provocation from jaw muscle trigger points (referred pain)
  3. PDAP with TMD:

    • Fulfilling diagnostic criteria for PDAP2 and chronic TMD myalgia per Schiffman et al. 20143

Exclusion Criteria:

Self-report:

  1. Chronic widespread pain
  2. Current use of opioids or other pain medications (e.g., ibuprofen/acetaminophen) that cannot be stopped <3 days prior to testing
  3. Conditions/diseases associated with altered pain perception: neurological (e.g., multiple sclerosis, trigeminal neuralgia) psychiatric disorders, diabetes, neoplasm and cardiovascular disorders
  4. Injury to hands
  5. Substance abuse
  6. MRI contraindications including pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630771


Contacts
Contact: Eva Counsell 612-626-0672 couns009@umn.edu

Locations
United States, Minnesota
University of Minnesota School of Dentistry Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Eva Counsell    612-626-0672    couns009@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Estephan J Moana-Filho, DDS, MS, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02630771     History of Changes
Other Study ID Numbers: 1511M80706
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Nervous System Diseases
Tooth Diseases
Facial Pain
Toothache
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms