NCT07079865

Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Saint Peters University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to track and investigate the outcomes of female patients with acute thoracolumbar compression fractures, focusing on pain management and functional improvement. The study will investigate patients whose compression fractures are within 3 months or less and measure pain scores, using the Numeric Rating Scale (NRS) and Brief Pain Inventory (BPI) and quality of life using the PROMIS questionnaire at 1-week prior to intervention and then 2 weeks, 3 months and 6 months post PNS implantation. The primary aim is to assess pain reduction among participants that receive the 60-day PNS intervention. The secondary aim is to analyze functional outcomes and quality of life documented in PROMs (Patient Reported Outcomes Measures) provided by CareSense a digital data collection system.

Conditions

• Thoracolumbar Compression Fractures

Interventions

Type	Name	Description
DEVICE	SPRINT PNS modulation system	Participants will receive treatment using the commercially available SPRINT PNS system. Their pain levels will be assessed using qualified scales including NRS and BPI and their quality of life using the PROMIS scale.

Timeline

• Start date: 2025-08-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-07-23
• Last updated: 2026-02-18

Locations

4 sites across 1 country: United States