NCT03249922

Quality of Life Outcomes in Spinal Cord Stimulation

A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.

Detailed description

This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.

Conditions

• Neuropathic Pain
• Low Back Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation	Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-07-22
• Completion: 2018-07-22
• First posted: 2017-08-15
• Last updated: 2018-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study