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

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630771
• Other study ID #: 1511M80706
• Status: Completed
• Start date: January 2016
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Toothache

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota School of Dentistry	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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