NCT04803214

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Mainstay Medical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	ReActiv8	Market-approved ReActiv8 device implanted

Timeline

• Start date: 2021-07-14
• Primary completion: 2024-09-04
• Completion: 2026-01-05
• First posted: 2021-03-17
• Last updated: 2026-01-23
• Results posted: 2025-04-13

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated device study