CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 203 enrolled
Drug / intervention
ReActiv8device
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/NCT04803214
NCT04803214N/ACompleted

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Mainstay Medical·interventional·Posted Mar 17, 2021·Updated Jan 23, 2026

In Brief

A clinical study evaluating ReActiv8 for Chronic Low-back Pain. Completed, enrolled 203 participants across 28 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 17, 2021
Enrollment StartJul 14, 2021
Primary CompletionSep 4, 2024
Study CompletionJan 5, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.3 years ago

Interventions

ReActiv8device

Market-approved ReActiv8 device implanted