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

Launched by SAINT PETERS UNIVERSITY HOSPITAL · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Peripheral Nerve Stimulation (PNS) to help women who have recently experienced a type of spine fracture called a thoracolumbar compression fracture. This condition causes significant back pain and makes daily activities difficult. The study aims to see if using PNS for 60 days can reduce pain and improve how well participants can function and enjoy their quality of life. Researchers will track pain levels and overall well-being before starting the treatment, and again at several points over the next six months.

Women aged 18 and older who have osteoporosis and a recent (within 3 months) spine fracture causing moderate to severe pain may be eligible. Participants should have tried common pain relievers like over-the-counter medications but still have pain that limits their activity. During the study, women will receive the PNS treatment and report their pain and quality of life through simple questionnaires using a digital system. The study excludes those with certain medical conditions, mental health issues affecting their ability to participate, or implanted heart devices. Importantly, while participants may be taking opioid pain medicines before the study, no new opioids will be added during the PNS treatment. This trial hopes to offer a new way to manage pain and improve daily function after spine fractures.

Gender

FEMALE

Eligibility 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.