Quality of Life Outcomes in Spinal Cord Stimulation

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain; Neuropathic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation

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.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Neurologic Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Spinal Cord Stimulation; Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Antonios Mammis, MD, mammisan@njms.rutgers.edu

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): July 22, 2018
• Study Completion (Actual): July 22, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 22, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: spinal cord stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Neuralgia
• Other Study ID Numbers: Pro20170000766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No