Clinical trial NCT03345472: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Overall Pain Efficacy Responder Rate
timeFrame: Baseline to 3 months
measure: Low Back Pain Efficacy Responder Rate
timeFrame: Baseline to 3 months
measure: Leg Pain Efficacy Responder Rate
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Pain Consultants of San Diego
state: California
city: Orange
country: United States
facility: Restore Orthopedics and Spine Center
state: California
city: Wilmington
country: United States
facility: Center for Interventional Pain and Spine
state: Delaware
city: Stockbridge
country: United States
facility: Pain Care
state: Georgia
city: Oxon Hill
country: United States
facility: National Spine and Pain
state: Maryland
city: Wyoming
country: United States
facility: Michigan Pain Consultants
state: Michigan
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management
state: Nevada
city: Voorhees
country: United States
facility: The Pain Management Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Neurosurgery Partners Pain Management
state: New York
city: Huntersville
country: United States
facility: Carolinas Pain Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Healthcare Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: Saint Luke's Neurosurgical Associates
state: Pennsylvania
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Trevose
country: United States
facility: Delaware Valley Pain and Spine Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Orthopaedics/Coastal Carolina Research Center
state: South Carolina
city: Spartanburg
country: United States
facility: Carolina Center for Advanced Management of Pain
state: South Carolina
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic Roanoke Memorial Hospital
state: Virginia
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
Study officials:
affiliation: Medtronic Restorative Therapies, Pain Therapy
name: Vectors Post Market Clinical Research Study Team
role: STUDY_DIRECTOR
References:
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.