RecruitingNCT07079865

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


Sponsor

Saint Peters University Hospital

Enrollment

15 participants

Start Date

Aug 7, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SPRINT PNS modulation system for people with thoracolumbar compression fractures. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESPRINT 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.


Locations(4)

University Orthopaedic Associates - Division of OrthoNJ

Avenel, New Jersey, United States

University Orthopaedic Associates - Division of OrthoNJ

Morganville, New Jersey, United States

University Center for Ambulatory Surgery (UCAS)

Somerset, New Jersey, United States

University Orthopaedic Associates - Division of OrthoNJ

Somerset, New Jersey, United States

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NCT07079865