ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

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).

Inclusion criteria

• 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

Exclusion criteria

• 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