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

February 14, 2026 updated by: Saint Peters University Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Avenel, New Jersey, United States, 07001
        • Recruiting
        • University Orthopaedic Associates - Division of OrthoNJ
        • Contact:
          • Dr. Tony George Principal Investigator
          • Phone Number: 732-283-2663
          • Email: drgeorge@uognj.com
      • Morganville, New Jersey, United States, 07751
        • Recruiting
        • University Orthopaedic Associates - Division of OrthoNJ
        • Contact:
          • Dr. Tony George Principal Investigator
          • Phone Number: 732-283-2663
          • Email: drgeorge@uognj.com
      • Somerset, New Jersey, United States, 08873
        • Recruiting
        • University Center for Ambulatory Surgery (UCAS)
        • Contact:
          • Dr. Tony George Principal Investigator
          • Phone Number: 732-283-2663
          • Email: drgeorge@uognj.com
      • Somerset, New Jersey, United States, 08873
        • Recruiting
        • University Orthopaedic Associates - Division of OrthoNJ
        • Contact:
          • Dr. Tony George Principal Investigator
          • Phone Number: 732-283-2663
          • Email: drgeorge@uognj.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatient Orthopedic Clinic

Description

Inclusion Criteria:

  • Adult females ages 18+
  • Osteoporosis diagnosis with acute/subacute insufficiency fractures of the thoracic or lumbar spine identified on MRI or X-ray with significant pain and activity limitation.
  • Onset of pain from associated fracture should be less than 3 months.
  • Minimum pain should be 4 or greater (Moderate) on the NRS scale and/or impairing their daily activity.
  • Patients reported pain should be despite OTC medication trials of NSAIDs, Tylenol, lidocaine patches or similar medications.
  • Patients may be taking opioids while receiving treatment however as per routine practice, no additional opioids will be prescribed during the PNS intervention.

Exclusion Criteria:

  • Patients with pathological fractures, other etiologies of fracture such as pagets disease, multiple myeloma, local or systemic infection, untreated coagulopathy, untreated psychosocial disease.
  • Other etiologies of osteoporosis other than primary osteoporosis will be excluded such as hyperparathyroidism, anorexia, malabsorption, hyperthyroidism, or overtreatment of hypothyroidism, chronic renal failure, cushing.
  • Patients with diminished mental capacity (mental condition that will inhibit their ability to complete the assessments) as determined by the investigator.
  • Patients with an active cardiac implant device such as a pacemaker or defibrillator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
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.
Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Change in Pain
Time Frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Pain as measured using a Brief Pain Inventory (BPI). A 0 - 10 point scale with 0 representing no pain and 10 representing severe pain.
Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life (QOL)
Time Frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
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.
Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Peters University Hospital

Collaborators

University Orthopaedic Associates - Division of OrthoNJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 7, 2025

First Submitted That Met QC Criteria

July 14, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2024-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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