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The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
Who can join
Ages 18 to 85 · All sexes · Healthy volunteers welcome
Full 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.
About the study
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.
Sponsor: Indiana University · Participants: 250 · Started: Jan 3, 2024
Contact the study team
- Fletcher A White, PhD · Phone: 317-274-5264
- Kelly Naugle, PhD · Phone: 317-274-5264
Official record on ClinicalTrials.gov — NCT06420141
Locations in the U.S.
| Indiana | Indiana University School of Medicine, Indianapolis |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.