Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Mainstay Medical

Recruitment countries:

Australia, Belgium, Netherlands, United Kingdom, United States

Health condition studied:

Chronic Low Back Pain

URL:

Link to the clinical trial website

About the trial

Interventions:

Device: ReActiv8 Implantable Stimulation System (Low Stimulation)
Device: ReActiv8 Implantable Stimulation System (Subject Appropriate Stimulation)

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  1. Age =22 years, =75 years
  
  2. Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
  
  3. Continuing low back pain despite >90 days of medical management.
  
  4. Qualifying pain score.
  
  5. Qualifying disability score.
  
  6. Evidence of lumbar multifidus muscle dysfunction.
  
  7. Be willing and capable of giving Informed Consent.
  
  8. Ability to comply with the instructions for use and to operate ReActiv8, and to comply
  with this Clinical Investigation Plan.
  
  9. Suitable for ReActiv8 surgery as determined by the implanting physician prior to
  inclusion.
  
  Exclusion Criteria:
  
  1. BMI > 35
  
  2. Back Pain characteristics:
  
  1. Any surgical correction procedure for scoliosis at any time, or a current
  clinical diagnosis of scoliosis.
  
  2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal
  canal of <10mm in subjects with lower extremity pain.
  
  3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
  
  4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or
  infection (e.g.: post herpetic neuralgia).
  
  5. Back pain due to inflammation or damage to the spinal cord or adjacent structures
  (e.g. arachnoiditis or syringomyelia).
  
  6. Pathology seen on MRI that is clearly identified and is likely the cause of the
  CLBP that is amenable to surgery.
  
  7. Back pain due to vascular causes such as aortic aneurysm and dissection.
  
  3. Any current indication for back surgery according to local institutional guidelines,
  or has indication for back surgery but cannot undergo surgery for other reasons.
  
  4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain)
  below the knee.
  
  5. Source of pain is the sacroiliac joint as determined by the Investigator.
  
  6. Drug use.
  
  7. Surgical and other procedures exclusions.
  
  8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or
  lumbar annular tear with disc protrusion that is amenable to surgery.
  
  9. Planned surgery.
  
  10. Co-morbid chronic pain conditions.
  
  11. Other clinical conditions.
  
  12. Psycho-social exclusions.
  
  13. Protocol compliance exclusions.
  
  14. General exclusions.
  

• Age minimum: 22 Years
• Age maximum: 75 Years
• Gender: All

Primary outcomes:

Primary Efficacy Endpoint
Primary Safety Assessment

Secondary outcomes:

Secondary Efficacy Endpoint

Target sample size:

128

Study type:

Interventional

Study design:

Contacts:

• Name: Chris Gilligan, MD, MBA
• Address:
• Phone:
• Email:
• Affiliation: Brigham and Women's Hospital

• Name: Diane Burnside
• Address:
• Phone:
• Email: diane.burnside@mainstay-medical.com
• Affiliation:

• Name: Meredith Langhorst, MD
• Address:
• Phone:
• Email:
• Affiliation:

Technical details

Scientific title:

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02577354

Secondary ID:

950057

Register:

ClinicalTrials.gov

Date of registration:

12/10/2024

Date of first enrollment:

August 2016

Last refreshed:

10 July 2024