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Trial record 1 of 13 for:    Medtronic Vectors
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Vectors Post Market: A Study to Assess Pain Relief Using 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: NCT03345472
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : March 20, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Pain
Intervention Device: Spinal Cord Stimulation System
Enrollment 175
Recruitment Details  
Pre-assignment Details 175 subjects were enrolled. 32 exited before the spinal cord stimulation trial. 143 subjects started the trial and 12 exited during the trial. 131 subjects completed the trial: 117 had a successful high dose (HD) trial; the 14 with unsuccessful HD trial were exited. Of the 117, 14 exited before implant and 103 were implanted (Treated Arm).
Arm/Group Title Treated
Hide Arm/Group Description

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

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

Period Title: Implant to 3 Months
Started 103
Completed 99
Not Completed 4
Reason Not Completed
Withdrawal by Subject             2
Physician Decision             1
Adverse Event             1
Period Title: 3 Months to 12 Months
Started 99
Completed 91
Not Completed 8
Reason Not Completed
Physician Decision             3
Lost to Follow-up             2
Withdrawal by Subject             1
Adverse Event             1
Death             1
Arm/Group Title Treated
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
60.8  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
56
  54.4%
Male
47
  45.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Hispanic or Latino
4
   3.9%
Not Hispanic or Latino
93
  90.3%
Unknown or Not Reported
6
   5.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
   9.7%
White
92
  89.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants
103
Years from pain onset to enrollment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
12.9  (11.1)
1.Primary Outcome
Title Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 103
Mean (Standard Error)
Unit of Measure: units on a scale
45.4  (2.6)
2.Secondary Outcome
Title Overall Pain Efficacy Responder Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of subjects who are responder
68.3
(59.0 to 77.5)
3.Secondary Outcome
Title Low Back Pain Efficacy Responder Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of subjects who are responders
59.8
(49.9 to 69.7)
4.Secondary Outcome
Title Leg Pain Efficacy Responder Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of subjects who are responders
77.4
(69.1 to 85.7)
Time Frame 12 months post-device activation
Adverse Event Reporting Description

Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected.

The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.

 
Arm/Group Title Treated
Hide Arm/Group Description

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

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

All-Cause Mortality
Treated
Affected / at Risk (%)
Total   1/103 (0.97%)    
Hide Serious Adverse Events
Treated
Affected / at Risk (%) # Events
Total   1/103 (0.97%)    
Musculoskeletal and connective tissue disorders   
Back pain  1  1/103 (0.97%)  1
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated
Affected / at Risk (%) # Events
Total   36/103 (34.95%)    
Musculoskeletal and connective tissue disorders   
Back pain  1  9/103 (8.74%)  10
Nervous system disorders   
Paraesthesia  1  19/103 (18.45%)  25
Product Issues   
Device stimulation issue  1  11/103 (10.68%)  14
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Per the Clinical Investigation Plan, all proposed publications must be reviewed and approved by Medtronic prior to publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stacie Hallaway/Senior Clinical Research Specialist
Organization: Medtronic Restorative Therapies Group, Spinal Cord Stimulation
Phone: 763-526-3844
EMail: RS.VectorsPM@medtronic.com
Layout table for additonal information
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03345472    
Other Study ID Numbers: MDT17053
First Submitted: November 14, 2017
First Posted: November 17, 2017
Results First Submitted: February 3, 2020
Results First Posted: March 20, 2020
Last Update Posted: November 3, 2020