Restore Claims Characterization Study

Phase 4CompletedNCT00200122

MedtronicNeuro100 enrolled

Overview

The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

100

Conditions

Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Interventions

Spinal Cord StimulationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD). * Primary pain in the lower half of the body. Exclusion Criteria: * Requires, or will in the future, diathermy treatments. * Had implanted spinal cord stimulation system within the last six months.

Locations (8)

Contact Medtronic for Exact Location

Chicago, Illinois, United States

Contact Medtronic for Exact Location

Indianapolis, Indiana, United States

Contact Medtronic for Exact Location

Kansas City, Missouri, United States

Contact Medtronic for Exact Location

Outcomes

Primary Outcomes

The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Secondary Outcomes

Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.