ReActiv8 for Chronic Low Back Pain (PMCF)

Inclusion criteria

• Age ≥ 18 years, ≤65 years
• Chronic Low Back Pain with a first occurrence >90 days prior to enrolment, and the last relatively pain-free time >90 days prior to enrolment.
• Continuing low back pain despite >90 days of medical management
• Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
• Able to understand and sign the Informed Consent form.
• Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
• Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
• Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit

Exclusion criteria

• BMI > 35
• Back Pain characteristics:

• Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
• Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain
• Neurological deficit possibly associated with the back pain (e.g. foot drop).
• Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
• Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia)
• Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
• Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
• Source of pain is the sacroiliac joint as determined by the Investigator.
• Drug use
• Surgical and other procedures exclusions
• Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion
• Planned surgery.
• Co-morbid chronic pain conditions
• Other clinical conditions
• Psycho-social exclusions
• Protocol Compliance Exclusions
• General exclusions