Recruiting

Neuropathic Pain

Sponsor:

Indiana University

Code:

NCT06420141

Conditions

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Neuropathic Pain

Study ID

NCT06420141

Start date

Jan 3, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Fracture Group

patients with qualifying ankle fractures

Control Group

Healthy controls without an ankle fracture

Primary outcome measure

  • Chronic Pain Grading Scale [ Time Frame: 6-9 month ]
  • Douleur Neuropathique (Neuropathic Pain) 4 [ Time Frame: 2 weeks to 1 year ]
  • Assessment of Chronic Regional Pain Syndrome (CRPS) [ Time Frame: 2 weeks to 6-9 months ]
  • Central Sensitization measure [ Time Frame: 5-9 weeks to 6-9 months ]
  • Pain Inhibitory Test [ Time Frame: 5-9 weeks to 6-9 months ]

Central Contacts and Locations

Central contacts

Fletcher A White, PhD

317-274-5264fawhite@iu.edu

Kelly Naugle, PhD

317-274-5264kmnaugle@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Fletcher A White, PhD

317-274-5164fawhite@iu.edu

Roman Natoli, MD PhD

rnatoli@iuheath.org

More Information

Sponsor

Indiana University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.