60-day peripheral nerve stimulation to reduce pain and improve function after acute thoracolumbar compression fracture
Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
This program will try 60-day SPRINT peripheral nerve stimulation in adult women with recent thoracolumbar compression fractures to see if it lowers pain and improves function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Saint Peters University Hospital Academic / other |
| Locations | 4 sites (Avenel, New Jersey and 3 other locations) |
| Trial ID | NCT07079865 on ClinicalTrials.gov |
What this trial studies
This observational study follows adult women with osteoporosis who have thoracic or lumbar compression fractures less than three months old and receive a 60-day SPRINT peripheral nerve stimulation (PNS) implant. Pain (Numeric Rating Scale and Brief Pain Inventory) and patient-reported outcomes (PROMIS via the CareSense digital system) are collected one week before implantation and at 2 weeks, 3 months, and 6 months after implantation. Participants may be taking opioids at baseline but, per routine practice, no additional opioids will be prescribed during the PNS intervention. The primary focus is on short-term pain reduction with secondary analysis of function and quality of life over six months.
Who should consider this trial
Good fit: Adult women (18+) with primary osteoporosis and an acute or subacute thoracic or lumbar compression fracture within the past three months who report at least moderate pain (NRS ≥4) despite OTC therapies are the ideal candidates.
Not a fit: Patients with pathological fractures from malignancy or other non-osteoporotic causes, active infection, untreated coagulopathy, uncontrolled psychosocial illness, or other excluded conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, 60-day PNS could reduce pain and improve daily function and quality of life for women with recent thoracolumbar compression fractures.
How similar studies have performed: Percutaneous short-term PNS systems such as SPRINT have shown pain reductions in other acute and postoperative pain settings, but their use specifically for thoracolumbar compression fractures is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Avenel, New Jersey and 3 other locations
- University Orthopaedic Associates - Division of OrthoNJ — Avenel, New Jersey, United States (Recruiting)
- University Orthopaedic Associates - Division of OrthoNJ — Morganville, New Jersey, United States (Recruiting)
- University Center for Ambulatory Surgery (UCAS) — Somerset, New Jersey, United States (Recruiting)
- University Orthopaedic Associates - Division of OrthoNJ — Somerset, New Jersey, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.