Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Understanding neuropathic pain after ankle fractures

Official title: The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture

Run by Indiana University · NCT06420141 · Data updated 2026-11-12

This study looks at how common nerve pain is after ankle fractures in adults aged 18-85 to better understand why some people still hurt after their bones heal.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment250 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedJanuary 3, 2024
Main results expectedMarch 31, 2027
Study endsDecember 31, 2027
Registry record updatedJune 26, 2026
Trial IDNCT06420141 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18-85 who have sustained an isolated rotational ankle fracture treated surgically.

Probably not a fit

Patients with a history of chronic pain conditions prior to their ankle injury or those who develop complications post-surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the prevalence of neuropathic pain that may develop following ankle fractures. It focuses on patients aged 18-85 who have sustained isolated rotational ankle fractures treated operatively. The study aims to identify the incidence of chronic pain after bone healing and explore the underlying mechanisms that may lead to persistent pain. By adhering to rigorous standards for study design, the research seeks to enhance the reproducibility and translational potential of findings related to chronic pain management.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of chronic neuropathic pain in patients recovering from ankle fractures.

How similar studies have gone: Other studies have indicated that understanding the mechanisms of neuropathic pain can lead to better management strategies, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Indiana University School of Medicine
    Indianapolis, Indiana, United States
    Recruiting

Study contacts

  • Principal investigator: Roman Natoli, MD, PhD — Indiana University
  • Study coordinator: Fletcher A White, PhD
  • Email: fawhite@iu.edu
  • Phone: 317-274-5264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.