Chronic PainNCT03345472

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

A study testing Spinal Cord Stimulation System in people with Chronic Pain, run by MedtronicNeuro at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Spinal Cord Stimulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 20 sitesUnited States
Study dates: 30 Nov 2017to 21 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

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

Conditions: Chronic Pain
Being tested: Spinal Cord Stimulation System
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal Cord Stimulation SystemDevice
Also called Medtronic RestoreSensor SureScan MRI neurostimulation system, Medtronic Intellis AdaptiveStim neurostimulation system
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.

Study groups in NCT03345472
Study group	Role	What they receive
Treated	Experimental	Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. Receives: Device: Spinal Cord Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 3 months

Secondary outcomes (3)

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).
Measured: 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).
Measured: 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).
Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201721 Oct 2019

First posted17 Nov 2017
Study start30 Nov 2017
Primary completion4 Feb 2019
Study completion21 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03345472
Sponsor's protocol ID: MDT17053
Status last verified: Oct 2020
First submitted: 14 Nov 2017
Last updated: 3 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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.
PubMed 33296127

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
ClinicalTrials.gov ID: NCT03345472
Acronym / sponsor ID: MDT17053
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 30 Nov 2017 (actual)
Primary completion: 4 Feb 2019 (actual)
Study completion: 21 Oct 2019 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 20 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treated	Experimental	Device: Spinal Cord Stimulation SystemEnrolled subjects who are implanted with a spinal cord stimulation system that is activated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal Cord Stimulation SystemAlso: Medtronic RestoreSensor SureScan MRI neurostimulation system, Medtronic Intellis AdaptiveStim neurostimulation systemImplanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.	Device	Treated

Primary outcome

Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
Time frame: Baseline to 3 months
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.

3 secondary outcomes

Overall Pain Efficacy Responder Rate
Time frame: Baseline to 3 months
Low Back Pain Efficacy Responder Rate
Time frame: Baseline to 3 months
Leg Pain Efficacy Responder Rate
Time frame: Baseline to 3 months

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated	103	99

Primary outcome: Change in Overall Pain Intensity on the Visual Analog Scale (0-100)

Time frame: Baseline to 3 months. Mean (Standard Error). Unit: units on a scale

Measure	Treated n = 103
Value	45.4 (2.6)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months post-device activation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated	1 of 103 (1%)	36 of 103 (35%)	1 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33296127Hatheway 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vectors Post Market Clinical Research Study Team study director

Medtronic Restorative Therapies, Pain Therapy

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation System in people with Chronic Pain, run by MedtronicNeuro at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Overall Pain Intensity on the Visual Analog Scale (0-100) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03345472, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.