Quality of Life Outcomes in Spinal Cord Stimulation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain, Neuropathic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>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. | Device: Spinal Cord Stimulation<br>* Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with at least 50% improvement in VAS Pain Score | The number of patients who had at least 50% improvement in VAS pain score | 12 Months | 
| The number of patients with at least 50% improvement in Owenstry low back disability index | The number of patients who had at least 50% improvement in disability as determined by this questionnaire. | 12 Months | 
| The number of patients with at least 50% improvement in WHODAS 12 disability index. | The number of patients who had at least 50% improvement in disability as determined by this questionnaire. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with at least 50% improvement in SF-36 quality of life score | The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire. | 12 months | 
| The number of patients with at least 50% improvement in beck depression inventory | The number of patients who had at least 50% improvement in depression as determined by this questionnaire. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation