Clinical trial NCT03249922: Quality of Life Outcomes in Spinal Cord Stimulation
Official title: A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuropathic Pain
Low Back Pain
Keywords: spinal cord stimulation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the functional neurosurgery and neuromodulation department at New Jersey Medical School who present for indicated spinal cord stimulation therapy.

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.

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.

Primary outcomes:
measure: The number of patients with at least 50% improvement in VAS Pain Score
timeFrame: 12 Months
measure: The number of patients with at least 50% improvement in Owenstry low back disability index
timeFrame: 12 Months
measure: The number of patients with at least 50% improvement in WHODAS 12 disability index.
timeFrame: 12 Months
Secondary outcomes:
measure: The number of patients with at least 50% improvement in SF-36 quality of life score
timeFrame: 12 months
measure: The number of patients with at least 50% improvement in beck depression inventory
timeFrame: 12 Months
Other outcomes:
measure: The Total number of surgical and post-operative Complications
timeFrame: 12 months
Locations:
city: Newark
country: United States
facility: Neurologic Institute of New Jersey
state: New Jersey
Study officials:
affiliation: mammisan@njms.rutgers.edu
name: Antonios Mammis, MD
role: PRINCIPAL_INVESTIGATOR
References: