ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Completed · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.

Key facts

Study ID

NCT02577354

Run by

Mainstay Medical

People needed

204

Starts

2016-08-01

Expected to finish

2024-01-01

Last updated by the study team

2025-02-27

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥22 years, ≤75 years
• Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
• Continuing low back pain despite >90 days of medical management.
• Qualifying pain score.
• Qualifying disability score.
• Evidence of lumbar multifidus muscle dysfunction.
• Be willing and capable of giving Informed Consent.
• Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
• Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.

You may not qualify if…

• 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).
• Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
• Back pain due to vascular causes such as aortic aneurysm and dissection.
• 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 that is amenable to surgery.
• Planned surgery.
• Co-morbid chronic pain conditions.
• Other clinical conditions.
• Psycho-social exclusions.
• Protocol compliance exclusions.
• General exclusions.

Where it is running

• University of California, San Diego — La Jolla, California, United States
• The Spine Institute — Santa Monica, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Indiana Spine Group — Carmel, Indiana, United States
• OrthoIndy — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beaumont Health — Royal Oak, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• Louis Stokes VA Medical Center — Cleveland, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Upstate Clinical Trials — Spartanburg, South Carolina, United States
• Northwest Orthopaedic Specialists — Spokane, Washington, United States
• Center for Pain Relief — Charleston, West Virginia, United States
• Genesis Research Services — Broadmeadow, New South Wales, Australia
• Sunshine Coast Clinical Research — Noosa, Queensland, Australia
• Pain Medicine of South Australia — Welland, South Australia, Australia
• Monash Clinical Research — Clayton, Victoria, Australia
• AZ Nikolaas — Sint-Niklaas, Belgium
• Sint Augustinus — Wilrijk, Belgium
• Erasmus MC University Medical Center — Rotterdam, Netherlands
• Seacroft Hospital — Leeds, United Kingdom
• St. Bartholomew's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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