The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
Recruiting now
Conditions studied: Neuropathic Pain
In brief
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.
Key facts
- Study ID
- NCT06420141
- Run by
- Indiana University
- People needed
- 250
- Starts
- 2024-01-03
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-85 years old
- an isolated rotational ankle (AO/OTA 44 types A-C) fracture that is treated operatively
- Abbreviated Injury Scale < 3 for non-extremity body systems
- can speak, read, and understand English
You may not qualify if…
- treated for a chronic pain condition prior to their qualifying injury
- on a pain contract
- pathologic fracture
- Daily use of gabapentin or opiods prior to enrollment
- Control Group:
- Inclusion Criteria:
- 18-85 years of age
- can speak, read, and understand English
- Exclusion Criteria:
- Chronic pain or an ongoing acute pain condition
- Currently or have previously sustained a bone fracture
- Current Pain medication usage
- Any previous orthopaedic surgical procedures
- Must have been free of any surgeries for at least 5 years
- Peripheral neuropathy
- 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.
Where it is running
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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