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

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ClinicalTrials.gov Identifier: NCT02577354
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mainstay Medical

Study Description
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Brief Summary:
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in conjunction with medical management.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: ReActiv8 Implantable Stimulation System (Subject Appropriate Stimulation) Device: ReActiv8 Implantable Stimulation System (Low Stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Study Start Date : August 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Device: ReActiv8 Implantable Stimulation System (Subject Appropriate Stimulation)
ReActiv8 implanted and configured to deliver stimulation at a Subject-appropriate level and subjects instructed to deliver stimulation in two 30-minute sessions per day.
Experimental: Control Device: ReActiv8 Implantable Stimulation System (Low Stimulation)
ReActiv8 implanted and configured to deliver low stimulation, and subjects instructed to deliver stimulation in two 30-minute sessions per day.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: 4 months ]

    Comparison of responder rates for low back pain VAS between Treatment and Control groups.

    The Primary Efficacy Endpoint is a comparison of responder rates between Treatment and Control groups, where a "responder" is a Subject with ≥30% reduction from baseline in average low back pain VAS.


  2. Primary Safety Assessment [ Time Frame: 4 months ]
    The primary safety assessment is of serious device and/or procedure related adverse events in all subjects in the Intent to Treat Cohort at the primary Endpoint Assessment visit.


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint [ Time Frame: 4 months ]
    Comparison of change in Oswestry Disability Index (ODI) between Treatment and Control groups at the Primary End Point Assessment Visit.

  2. Secondary Efficacy Endpoint [ Time Frame: 4 months ]
    Comparison of change in EQ-5D between Treatment and Control groups at the Primary End Point Assessment Visit.


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577354


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Sponsors and Collaborators
Mainstay Medical
Investigators
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Study Chair: Chris Gilligan, MD, MBA Brigham and Women's Hospital
More Information
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Responsible Party: Mainstay Medical
ClinicalTrials.gov Identifier: NCT02577354     History of Changes
Other Study ID Numbers: 950057
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms