Quality of Life Outcomes in Spinal Cord Stimulation

NCT ID: NCT03249922

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-27
• Study Completion Date: 2018-07-22

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Group

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.

Spinal Cord Stimulation

Intervention Type: DEVICE

Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

Interventions

Spinal Cord Stimulation

Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Antonios Mammis MD

Director, Center for Neuromodulation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonios Mammis, MD

Role: PRINCIPAL_INVESTIGATOR

mammisan@njms.rutgers.edu

Locations

Neurologic Institute of New Jersey

Newark, New Jersey, United States

Countries

United States

Other Identifiers

Pro20170000766

Identifier Type: -

Identifier Source: org_study_id