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

NCT02630771 | Completed

• 1 other identifier: 1511M80706
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Toothache; Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold change before and during conditioned pain modulation

  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.

  Baseline

Study Arms (3)

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

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

Painfree controls

Painfree subjects. Pressure pain threshold before/during conditioned pain modulation.

Procedure: Pressure pain threshold

Interventions

Pressure pain threshold PROCEDURE

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

Also known as: PPT

PDAP + TMD; PDAP only; Painfree controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with age range 18-65 years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Toothache; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Study Officials

• Estephan J Moana-Filho, DDS, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

US (1)