Actively Recruiting
Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
Led by Saint Peters University Hospital · Updated on 2026-02-18
15
Participants Needed
4
Research Sites
68 weeks
Total Duration
On this page
Sponsors
S
Saint Peters University Hospital
Lead Sponsor
U
University Orthopaedic Associates - Division of OrthoNJ
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults aged 18 years or older
- Diagnosed with osteoporosis and acute or subacute thoracic or lumbar spine fracture confirmed by MRI or X-ray
- Onset of pain from the fracture less than 3 months ago
- Pain level of 4 or greater on the Numeric Rating Scale or daily activity impairment due to pain
- Pain persists despite use of over-the-counter medications such as NSAIDs, Tylenol, or lidocaine patches
- Patients may be using opioids but no additional opioids will be prescribed during the intervention
You will not qualify if you...
- Fractures caused by diseases like Paget's disease, multiple myeloma, infections, untreated blood clotting disorders, or untreated psychosocial conditions
- Osteoporosis due to secondary causes such as hyperparathyroidism, anorexia, malabsorption, hyperthyroidism, overtreatment of hypothyroidism, chronic kidney failure, or Cushing's syndrome
- Patients with mental conditions preventing completion of assessments
- Presence of active cardiac implant devices like pacemakers or defibrillators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Orthopaedic Associates - Division of OrthoNJ
Avenel, New Jersey, United States, 07001
Actively Recruiting
2
University Orthopaedic Associates - Division of OrthoNJ
Morganville, New Jersey, United States, 07751
Actively Recruiting
3
University Center for Ambulatory Surgery (UCAS)
Somerset, New Jersey, United States, 08873
Actively Recruiting
4
University Orthopaedic Associates - Division of OrthoNJ
Somerset, New Jersey, United States, 08873
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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