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NCT06420141
The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
Conditions: Neuropathic Pain
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: Yes
Enrollment: 250
Sponsor: Indiana University
Location: Indiana University School of Medicine Indianapolis Indiana
Summary
This application addresses the Peer Reviewed Medical Research Program Investigator-Initiated Research Award FY21 W81XWH-22-CPMRP-IIRA area of Chronic Pain Management Research Program- The investigators will utilize subjects who have sustained ankle fractures and may develop chronic pain following bone union. No attempt will be made to affect the experimental outcome in the subjects. This study will adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research.
Eligibility Criteria
Fracture Group:
Inclusion Criteria:
1. 18-85 years old
2. an isolated rotational ankle (AO/OTA 44 types A-C) fracture that is treated operatively
3. Abbreviated Injury Scale \< 3 for non-extremity body systems
4. can speak, read, and understand English
Exclusion Criteria:
1. treated for a chronic pain condition prior to their qualifying injury
2. on a pain contract
3. pathologic fracture
4. Daily use of gabapentin or opiods prior to enrollment
Control Group:
Inclusion Criteria:
1. 18-85 years of age
2. can speak, read, and understand English
Exclusion Criteria:
1. Chronic pain or an ongoing acute pain condition
2. Currently or have previously sustained a bone fracture
3. Current Pain medication usage
4. Any previous orthopaedic surgical procedures
5. Must have been free of any surgeries for at least 5 years
6. Peripheral neuropathy
7. Individuals having had a major surgery or a major disease or condition, as determined by the PI, such as cardiovascular disease, metabolic disorders, renal disease, neurological disorders, or severe psychiatric conditions.
Source: ClinicalTrials.gov (NCT06420141). StuddyBuddy aggregates publicly available trial information.