NCT06420141 The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
| NCT ID | NCT06420141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Neuropathic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-01-03 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-01-03 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Roman Natoli, MD, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06420141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06420141 currently recruiting?
Yes, NCT06420141 is actively recruiting participants. Contact the research team at fawhite@iu.edu for enrollment information.
Where is the NCT06420141 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06420141 clinical trial?
NCT06420141 is sponsored by Indiana University. The principal investigator is Roman Natoli, MD, PhD at Indiana University. The trial plans to enroll 250 participants.