ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of...

Area of Science:

• Neurology
• Pain Management
• Medical Devices

Background:

• Chronic low back pain (CLBP) is a global health issue, causing significant disability.
• Restorative neurostimulation has shown promise for refractory CLBP with multifidus muscle dysfunction.
• Previous studies indicate safety and clinical benefits of this treatment.

Purpose of the Study:

• To compare restorative neurostimulation plus optimal medical management against optimal medical management alone.
• To test if adding restorative neurostimulation improves back pain-related disability.
• To evaluate long-term outcomes in patients with chronic low back pain.

Main Methods:

• A randomized controlled trial comparing two groups: optimal medical management vs. optimal medical management plus ReActiv8® restorative neurostimulation.
• Inclusion criteria: persistent back pain and disability for over 6 months.
• Patient-reported outcomes collected for 1 year, with continued follow-up.

Main Results:

• NCT04803214 is the registration number for this clinical trial.
• The trial is designed to assess the efficacy of restorative neurostimulation.
• Data collection is ongoing, with primary endpoint at 1 year.

Conclusions:

• The study aims to provide direct comparison data for restorative neurostimulation in CLBP.
• Results will inform clinical practice regarding neurostimulation for back pain.
• Further analysis will determine the long-term impact and patient benefits.