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NCT07079865 · ClinicalTrials.gov registry record
Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
A clinical trial of Thoracolumbar Compression Fractures, sponsored by Saint Peters University Hospital.
- Recruiting
- Registry status
- 15
- Enrollment target
- 4
- Study locations
NCT07079865: Recruiting study of Thoracolumbar Compression Fractures, sponsored by Saint Peters University Hospital.
NCT07079865 is a study of Thoracolumbar Compression Fractures that is actively recruiting participants, run by Saint Peters University Hospital. The registered enrollment target is 15 participants. The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07079865, a study of Thoracolumbar Compression Fractures, is actively recruiting participants, sponsored by Saint Peters University Hospital.
- RECRUITING
- Registry status
- 15 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Pain as measured using a numeric rating scale (NRS). A 0 - 10 point scale with 0 representing no pain, 1-3 mild, 4-6 moderate and 7-10 severe.
Conditions Studied
Interventions
- DEVICE SPRINT PNS modulation system
Study Locations (4)
New Jersey
- University Orthopaedic Associates - Division of OrthoNJ - Avenel
- University Orthopaedic Associates - Division of OrthoNJ - Morganville
- University Center for Ambulatory Surgery (UCAS) - Somerset
- University Orthopaedic Associates - Division of OrthoNJ - Somerset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-07 |
| Est. Completion | 2026-12 |
What NCT07079865 shows while recruiting
NCT07079865 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 1 condition, with Thoracolumbar Compression Fractures appearing as the primary indexed condition, and to 1 intervention - of which SPRINT PNS modulation system is the first listed.
NCT07079865 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07079865 about?
NCT07079865 is a clinical study titled "Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture". 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 s...
What is the current status of trial NCT07079865?
This trial is currently recruiting. The enrollment target is 15 participants. The study started on 2025-08-07. Estimated completion is 2026-12.
What conditions does trial NCT07079865 study?
This clinical trial studies the following conditions: Thoracolumbar Compression Fractures.
What interventions are being tested in trial NCT07079865?
The interventions under investigation include: SPRINT PNS modulation system (DEVICE).
Who is sponsoring clinical trial NCT07079865?
This trial is sponsored by Saint Peters University Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07079865 being conducted?
This trial has 4 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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