Quality of Life Outcomes in Spinal Cord Stimulation

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Neuropathic Pain; Low Back Pain

Treatments: Device: Spinal Cord Stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT03249922

Pro20170000766

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.
• Ages 18-90 with no ethnicity or gender predilections.

Exclusion criteria

• Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.

Trial design

6 participants in 1 patient group

Treatment Group

Description:

All patients who are considered candidates for spinal cord stimulator implant will be assigned to the "Treatment Group". Participiants will be clinically evaluated and given the Owenstry low back disability index, WHODAS 12, Beck depression index and SF-36.

Treatment:

Device: Spinal Cord Stimulation