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ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

NCT02577354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-02-27

Study results available
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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.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)

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.

DEVICE

ReActiv8 Implantable Stimulation System (Low Stimulation)

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

Sponsors & Collaborators

  • Mainstay Medical

    lead INDUSTRY

Principal Investigators

  • Chris Gilligan, MD, MBA · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-11-30
Completion
2024-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577354 on ClinicalTrials.gov