MedPath

FDG PET/MR Imaging of Peripheral Pain Generators

Not yet recruiting
Conditions
Pain
Nociceptive Pain
Registration Number
NCT06171659
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
128
Inclusion Criteria

Inclusion Criteria: Persistent Post-Surgical Pain Patients<br><br> - 18-85 years old<br><br> - Presents with persistent pain with pain score of =4 on Numerical Rating Scale [0:10]<br> for at least 6 months following joint arthroplasty or arthroscopy.<br><br> - Able and willing to provide informed consent<br><br> - Willing and able to undergo PET/MRI (arthroplasty and arthroscopy participants) and<br> PET/CT (arthroplasty participants only)<br><br>Inclusion Criteria: Asymptomatic controls<br><br> - 18-85 years old<br><br> - Asymptomatic (pain score of =2 on the NRS) for at least 6 months following joint<br> arthroplasty or arthroscopy.<br><br> - Able and willing to provide informed consent<br><br> - Willing and able to undergo PET/MRI<br><br>Exclusion Criteria:<br><br> - Inability to understand and communicate with the investigators to complete the<br> study-related questionnaires.<br><br> - Any co-morbidity which results in severe systemic disease limiting function as<br> defined by the American Society of Anesthesiology (ASA) physical status<br> classification > 3, such as the presence of current or past (6 months) pulmonary,<br> hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not<br> related to chronic pain.<br><br> - Pregnant or breastfeeding. (Individuals with childbearing potential will be asked to<br> verbally confirm they are not pregnant. If they cannot confirm, they will have a<br> urine pregnancy test either at the imaging study visit or within 7 days prior to the<br> imaging study visit.)<br><br> - Subject with contraindication(s) to or inability to undergo PET/MRI<br><br> - Current diagnosis of malignancy of any kind. Participants in remission for at least<br> two years and not undergoing any treatment may be considered per investigator<br> discretion<br><br> - Current enrollment in a scientific interventional or treatment study.<br><br> - Subject unable or unwilling to provide informed consent

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in SUVmax (chronic pain);SUVmax (chronic pain vs healthy);Location of Pain Compared to Target-to-Background (TTB) or SUVmax
Secondary Outcome Measures
NameTimeMethod
Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups);Variation of the maximum ratio of SUV (SUVRmax) in asymptomatic controls vs symptomatic;Variation of the maximum ratio of SUV (SUVRmax) in symptomatic participants;Radiology Review Scores;Change in Pain Scores (chronic pain)
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