Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters

This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation System

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942-8901
      • Pain Consultants of San Diego
    • Orange, California, United States, 92868
      • Restore Orthopedics and Spine Center
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Center for Interventional Pain and Spine
  • Georgia
    • Stockbridge, Georgia, United States, 30281-5023
      • Pain Care
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • National Spine and Pain
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Michigan Pain Consultants
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive and Interventional Pain Management
  • New Jersey
    • Voorhees, New Jersey, United States, 08043-3512
      • The Pain Management Center
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester Neurosurgery Partners Pain Management
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolinas Pain Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Healthcare Network
    • Bethlehem, Pennsylvania, United States, 18015
      • Saint Luke's Neurosurgical Associates
    • Sewickley, Pennsylvania, United States, 15134
      • Pain Diagnostics and Interventional Care
    • Trevose, Pennsylvania, United States, 19053
      • Delaware Valley Pain and Spine Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Orthopaedics/Coastal Carolina Research Center
    • Spartanburg, South Carolina, United States, 29303
      • Carolina Center for Advanced Management of Pain
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic Roanoke Memorial Hospital
  • Washington
    • Spokane, Washington, United States, 99201
      • Northwest Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
• Presence of low back and leg pain
• Moderate to crippled disability due to pain
• Stable pain medications for back and leg pain for at least 28 days prior to enrollment
• Willing and able to not increase pain medications through the 3-Month visit

Exclusion Criteria:

• Previously trialed or implanted with stimulator or intrathecal drug delivery system
• Current diagnosis of moderate to severe central lumbar spinal stenosis
• Major psychiatric comorbidity or other progressive diseases
• Serious drug-related behavioral issues
• Pregnant or planning on becoming pregnant
• Unable to achieve supine position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated; Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.	Device: Spinal Cord Stimulation System; Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.; Other Names: Medtronic RestoreSensor SureScan MRI neurostimulation system; Medtronic Intellis AdaptiveStim neurostimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)	Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Pain Efficacy Responder Rate	Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders).	Baseline to 3 months
Low Back Pain Efficacy Responder Rate	Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders).	Baseline to 3 months
Leg Pain Efficacy Responder Rate	Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders).	Baseline to 3 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Vectors Post Market Clinical Research Study Team, Medtronic Restorative Therapies, Pain Therapy

Publications and helpful links

General Publications

• Hatheway JA, Mangal V, Fishman MA, Kim P, Shah B, Vogel R, Galan V, Severyn S, Weaver TE, Provenzano DA, Chang E, Verdolin MH, Howes G, Villarreal A, Falowski S, Hendrickson K, Stromberg K, Davies L, Johanek L, Kelly MT. Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Neuromodulation. 2021 Apr;24(3):556-565. doi: 10.1111/ner.13324. Epub 2020 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: MDT17053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes