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Completed

NCT Number: NCT02630771

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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)
  • PDAP with TMD:
  • Fulfilling diagnostic criteria for PDAP2 and chronic TMD myalgia per Schiffman et al. 20143

Exclusion criteria

Self-report:

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

Treatment and study plan

Pressure pain threshold

Procedure

Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation

Other names: PPT

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2015
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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