Recruiting

PNS

Sponsor:

Saint Peters University Hospital

Code:

NCT07079865

Conditions

Thoracolumbar Compression Fractures

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPRINT PNS modulation system

Study Details

Brief 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

Study ID

NCT07079865

Start date

Aug 7, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Change in Pain [ Time Frame: 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 ]

Central Contacts and Locations

Locations

University Orthopaedic Associates - Division of OrthoNJ

Recruiting

Avenel, New Jersey, United States, 07001

Contacts

Dr. Tony George Principal Investigator

732-283-2663drgeorge@uognj.com

University Orthopaedic Associates - Division of OrthoNJ

Recruiting

Morganville, New Jersey, United States, 07751

Contacts

Dr. Tony George Principal Investigator

732-283-2663drgeorge@uognj.com

University Center for Ambulatory Surgery (UCAS)

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Dr. Tony George Principal Investigator

732-283-2663drgeorge@uognj.com

University Orthopaedic Associates - Division of OrthoNJ

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Dr. Tony George Principal Investigator

732-283-2663drgeorge@uognj.com

More Information

Sponsor

Saint Peters University Hospital

Last update posted

Feb 18, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Saint Peters University Hospital on 2026-02-18.