Thoracolumbar Compression Fractures
Conditions
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.
Interventions
DEVICESPRINT 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.
Sponsors
Saint Peters University Hospital
University Orthopaedic Associates - Division of OrthoNJ
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation | Pain as measured using a numeric rating scale (NRS). A 0 - 10 point scale with 0 representing no pain, 1-3 mild, 4-6 moderate and 7-10 severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) | Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation | QOL as measured by PROMIS (Patient-Reported Outcomes Measurement Information System). Responses are scored on 20 to 80 point scale. Scores between 20-55 are within normal limits. Scores 55+ will fall within mild-moderate-severe. |
Countries
United States
Outcome results
None listed