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Quality of Life Outcomes in Spinal Cord Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249922
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : August 15, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Antonios Mammis MD, Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment
Neuropathic Pain Low Back Pain 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.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : July 22, 2018
Actual Study Completion Date : July 22, 2018

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.




Primary Outcome Measures :
  1. The number of patients with at least 50% improvement in VAS Pain Score [ Time Frame: 12 Months ]
    The number of patients who had at least 50% improvement in VAS pain score

  2. The number of patients with at least 50% improvement in Owenstry low back disability index [ Time Frame: 12 Months ]
    The number of patients who had at least 50% improvement in disability as determined by this questionnaire.

  3. The number of patients with at least 50% improvement in WHODAS 12 disability index. [ Time Frame: 12 Months ]
    The number of patients who had at least 50% improvement in disability as determined by this questionnaire.


Secondary Outcome Measures :
  1. The number of patients with at least 50% improvement in SF-36 quality of life score [ Time Frame: 12 months ]
    The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire.

  2. The number of patients with at least 50% improvement in beck depression inventory [ Time Frame: 12 Months ]
    The number of patients who had at least 50% improvement in depression as determined by this questionnaire.


Other Outcome Measures:
  1. The Total number of surgical and post-operative Complications [ Time Frame: 12 months ]
    Total number of surgical and post-operative complications occurring during the study



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249922


Locations
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United States, New Jersey
Neurologic Institute of New Jersey
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Antonios Mammis, MD mammisan@njms.rutgers.edu
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Responsible Party: Antonios Mammis MD, Director, Center for Neuromodulation, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03249922    
Other Study ID Numbers: Pro20170000766
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.

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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
Keywords provided by Antonios Mammis MD, Rutgers, The State University of New Jersey:
spinal cord stimulation
Additional relevant MeSH terms:
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Neuralgia
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases