60-day peripheral nerve stimulation to reduce pain and improve function after acute thoracolumbar compression fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vessel-X Bone Filling Container System for Vertebral Augmentation

  A new minimally invasive vertebral augmentation approach tests the Vessel-X device to see if it safely improves pain and function in people with osteoporotic vertebral compression fractures.

  Recruiting at 2 sites National Defense Medical Center, Taiwan · Taipei and 1 other locations · NCT07665424

• Nine-grid Zoning Method to guide vertebroplasty for osteoporotic vertebral fractures

  This trial tests whether the Nine-grid Zoning Method can make percutaneous vertebroplasty safer and faster for adults with single-segment lumbar osteoporotic vertebral compression fractures.

  Recruiting Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT07616583

• Vertebroplasty versus sham to see if activity and mobility improve after osteoporotic vertebral fractures

  This study tests whether vertebroplasty, compared with a sham procedure, increases physical activity and mobility in people aged 50+ with recent painful osteoporotic vertebral compression fractures.

  Recruiting Spine Centre of Southern Denmark · Kolding · NCT06776003

• Evaluating treatment outcomes for vertebral compression fractures

  This study is testing how well a procedure called vertebroplasty helps adults with osteoporosis-related spine fractures feel better and improve their quality of life.

  Recruiting Hirslanden Clinique Bois-Cerf Lausanne · Lausanne · NCT06670404

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.