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

Medtronic

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345472

MDT17053

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

Treated

Experimental group

Description:

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

Treatment:

Device: Spinal Cord Stimulation System