Quality of Life Outcomes in Spinal Cord Stimulation

NCT03249922 | Terminated FDA Device

• 1 other identifier: Pro20170000766
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Low Back Pain

Keywords

spinal cord stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The number of patients with at least 50% improvement in SF-36 quality of life score

  12 months

• The number of patients with at least 50% improvement in beck depression inventory

  12 Months

Other Outcomes (1)

• The Total number of surgical and post-operative Complications

  12 months

Study Arms (1)

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

Interventions

Spinal Cord Stimulation DEVICE

Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Neurologic Institute of New Jersey

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Neuralgia; Low Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Antonios Mammis, MD

  mammisan@njms.rutgers.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Neuromodulation

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: October 27, 2017
• Primary Completion: July 22, 2018
• Study Completion: July 22, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)