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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation System
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Consultants of San Diego
  • Restore Orthopedics and Spine Center
  • Center for Interventional Pain and Spine
  • Pain Care
  • National Spine and Pain
  • Michigan Pain Consultants
  • Comprehensive and Interventional Pain Management
  • The Pain Management Center
  • University of Rochester Neurosurgery Partners Pain Management
  • Carolinas Pain Center
  • The Ohio State University Wexner Medical Center
  • Lehigh Valley Healthcare Network
  • Saint Luke's Neurosurgical Associates
  • Pain Diagnostics and Interventional Care
  • Delaware Valley Pain and Spine Institute
  • Lowcountry Orthopaedics/Coastal Carolina Research Center
  • Carolina Center for Advanced Management of Pain
  • Precision Spine Care
  • Carilion Clinic Roanoke Memorial Hospital
  • Northwest Pain Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
November 14, 2017
Last Updated
October 13, 2020
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT03345472
Brief Title
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Official Title
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation System
Other Intervention Name(s)
Medtronic RestoreSensor SureScan MRI neurostimulation system, Medtronic Intellis AdaptiveStim neurostimulation system
Intervention Description
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Primary Outcome Measure Information:
Title
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
Description
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.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Overall Pain Efficacy Responder Rate
Description
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).
Time Frame
Baseline to 3 months
Title
Low Back Pain Efficacy Responder Rate
Description
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).
Time Frame
Baseline to 3 months
Title
Leg Pain Efficacy Responder Rate
Description
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).
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vectors Post Market Clinical Research Study Team
Organizational Affiliation
Medtronic Restorative Therapies, Pain Therapy
Official's Role
Study Director
Facility Information:
Facility Name
Pain Consultants of San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942-8901
Country
United States
Facility Name
Restore Orthopedics and Spine Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Pain Care
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281-5023
Country
United States
Facility Name
National Spine and Pain
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Michigan Pain Consultants
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Comprehensive and Interventional Pain Management
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
The Pain Management Center
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043-3512
Country
United States
Facility Name
University of Rochester Neurosurgery Partners Pain Management
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Carolinas Pain Center
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lehigh Valley Healthcare Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Saint Luke's Neurosurgical Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Pain Diagnostics and Interventional Care
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15134
Country
United States
Facility Name
Delaware Valley Pain and Spine Institute
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Lowcountry Orthopaedics/Coastal Carolina Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Carolina Center for Advanced Management of Pain
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Carilion Clinic Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Northwest Pain Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33296127
Citation
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.
Results Reference
derived

Learn more about this trial

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

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