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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345472
• Other study ID #: MDT17053
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: October 21, 2019

Study information

• Verified date: October 2020
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 21, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.

Locations

Country	Name	City	State
United States	Lehigh Valley Healthcare Network	Allentown	Pennsylvania
United States	Saint Luke's Neurosurgical Associates	Bethlehem	Pennsylvania
United States	Lowcountry Orthopaedics/Coastal Carolina Research Center	Charleston	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Comprehensive and Interventional Pain Management	Henderson	Nevada
United States	Carolinas Pain Center	Huntersville	North Carolina
United States	Pain Consultants of San Diego	La Mesa	California
United States	Restore Orthopedics and Spine Center	Orange	California
United States	National Spine and Pain	Oxon Hill	Maryland
United States	Carilion Clinic Roanoke Memorial Hospital	Roanoke	Virginia
United States	University of Rochester Neurosurgery Partners Pain Management	Rochester	New York
United States	Pain Diagnostics and Interventional Care	Sewickley	Pennsylvania
United States	Carolina Center for Advanced Management of Pain	Spartanburg	South Carolina
United States	Northwest Pain Care	Spokane	Washington
United States	Pain Care	Stockbridge	Georgia
United States	Delaware Valley Pain and Spine Institute	Trevose	Pennsylvania
United States	Precision Spine Care	Tyler	Texas
United States	The Pain Management Center	Voorhees	New Jersey
United States	Center for Interventional Pain and Spine	Wilmington	Delaware
United States	Michigan Pain Consultants	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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