CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 204 enrolled
Drug / intervention
ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02577354
NCT02577354N/ACompleted
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ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)

Mainstay Medical·interventional·Posted Oct 16, 2015·Updated Feb 27, 2025

In Brief

A clinical study evaluating ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) and ReActiv8 Implantable Stimulation System (Low Stimulation) for Chronic Low Back Pain. Completed, enrolled 204 participants across 26 sites in 5 countries.

Detailed Summary

The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesAustralia, Belgium, Netherlands, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 16, 2015
Enrollment StartAug 1, 2016
Primary CompletionNov 1, 2018
Study CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.7 years ago

Interventions

ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)device

ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.

ReActiv8 Implantable Stimulation System (Low Stimulation)device

ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.