MedTrace Logo

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

NCT04803214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2026-01-23

Study results available
· View outcomes & findings →

Summary

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

ReActiv8

Market-approved ReActiv8 device implanted

Sponsors & Collaborators

  • Mainstay Medical

    lead INDUSTRY

Principal Investigators

  • Frank Schwab · New York-Presbyterian

  • Chris Gilligan · Brigham and Women's Hospital

  • Kiran Patel · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2024-09-04
Completion
2026-01-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04803214 on ClinicalTrials.gov