Understanding neuropathic pain after ankle fractures
The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
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 type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06420141 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-85 who have sustained an isolated rotational ankle fracture treated surgically.
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.
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 performed: Other studies have indicated that understanding the mechanisms of neuropathic pain can lead to better management strategies, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.