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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 : Completed
First Posted : December 15, 2015
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date December 2, 2015
First Posted Date December 15, 2015
Last Update Posted Date May 2, 2019
Study Start Date January 2016
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2016)
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.
Original Primary Outcome Measures
 (submitted: December 10, 2015)
Pressure pain threshold 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.
Change History Complete list of historical versions of study NCT02630771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
Official Title Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Females with age range 18-65 years
Condition
  • Toothache
  • Temporomandibular Joint Disorders
Intervention Procedure: Pressure pain threshold
Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
Other Name: PPT
Study Groups/Cohorts
  • PDAP only
    Persistent dentoalveolar pain disorder patients who do not fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation.
    Intervention: 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.
    Intervention: Procedure: Pressure pain threshold
  • Painfree controls
    Painfree subjects. Pressure pain threshold before/during conditioned pain modulation.
    Intervention: Procedure: Pressure pain threshold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
39
Original Estimated Enrollment
 (submitted: December 10, 2015)
64
Actual Study Completion Date March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02630771
Other Study ID Numbers 1511M80706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborators Not Provided
Investigators
Principal Investigator: Estephan J Moana-Filho, DDS, MS, PhD University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date April 2019