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.
Study Type
OBSERVATIONAL
Enrollment
15
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.
University Orthopaedic Associates - Division of OrthoNJ
Avenel, New Jersey, United States
RECRUITINGUniversity Orthopaedic Associates - Division of OrthoNJ
Morganville, New Jersey, United States
RECRUITINGUniversity Center for Ambulatory Surgery (UCAS)
Somerset, New Jersey, United States
RECRUITINGUniversity Orthopaedic Associates - Division of OrthoNJ
Somerset, New Jersey, United States
RECRUITINGChange in Pain
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.
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Change in Pain
Pain as measured using a Brief Pain Inventory (BPI). A 0 - 10 point scale with 0 representing no pain and 10 representing severe pain.
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Change in Quality of Life (QOL)
QOL as measured by PROMIS (Patient-Reported Outcomes Measurement Information System). Responses are scored on 20 to 80 point scale. Scores between 20-55 are within normal limits. Scores 55+ will fall within mild-moderate-severe.
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
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