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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Total number of surgical and post-operative Complications | Total number of surgical and post-operative complications occurring during the study | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients of the functional neurosurgery and neuromodulation department at New Jersey Medical School who present for indicated spinal cord stimulation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Antonios Mammis, MD | mammisan@njms.rutgers.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologic Institute of New Jersey | Newark | New Jersey | 07103 | United States |
No IPD will be shared with other researchers.
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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The number of patients who had at least 50% improvement in depression as determined by this questionnaire. |
| 12 Months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |