ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Completed · Not applicable

Conditions studied: Chronic Low-back Pain

In brief

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

Key facts

Study ID

NCT04803214

Run by

Mainstay Medical

People needed

203

Starts

2021-07-14

Expected to finish

2026-01-05

Last updated by the study team

2026-01-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥21 years
• Evidence of lumbar multifidus muscle dysfunction
• Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
• Failed therapy including pain medications and physical therapy
• Not a candidate for spine surgery
• Low Back Pain NRS of ≥6 and ≤9
• Oswestry Disability Index score ≥30 and ≤60
• Willing and capable of giving Informed Consent
• Able to comply with this protocol
• On Optimal Medical Management per the Investigator

You may not qualify if…

• Contraindicated for the ReActiv8 System
• BMI > 35
• Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
• An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
• Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
• Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy
• Surgical and other procedure exclusions
• Psycho-social exclusions
• Protocol compliance exclusions
• General exclusions

Where it is running

• Barrow Brain & Spine — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• SoCal Sport and Spine — Newport Beach, California, United States
• Pacific Research Institute — Santa Rosa, California, United States
• University of Colorado — Aurora, Colorado, United States
• International Spine, Pain and Performance Center — Washington D.C., District of Columbia, United States
• Cleveland Clinic Martin Health Tradition Hospital — Port Saint Lucie, Florida, United States
• Cantor Spine Center and Paley Orthopedic Spine Institute — West Palm Beach, Florida, United States
• Augusta Orthopedic & Sports Medicine Specialists — Augusta, Georgia, United States
• Horizon Clinical Research — Fayetteville, Georgia, United States
• Vista Clinical Research — Newnan, Georgia, United States
• Indiana Spine Group — Carmel, Indiana, United States
• OrthoIndy — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Advent Health Shawnee Mission — Shawnee Mission, Kansas, United States
• Columbia Orthopedic Group — Columbia, Missouri, United States
• SSM Health Medical Group — Jefferson City, Missouri, United States
• Freeman Hospital — Joplin, Missouri, United States
• Northwell Health — Great Neck, New York, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• OrthoCarolina Sports Medicine Center — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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