Quality of Life Outcomes in Spinal Cord Stimulation
Status: | Terminated |
---|---|
Conditions: | Back Pain, Back Pain, Neurology |
Therapuetic Areas: | Musculoskeletal, Neurology |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 7/26/2018 |
Start Date: | October 27, 2017 |
End Date: | July 22, 2018 |
A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
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.
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.
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.
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.
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