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

Mainstay Medical

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation); Device: ReActiv8 Implantable Stimulation System (Low Stimulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02577354

950057

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups

Treatment

Experimental group

Treatment:

Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)

Control

Experimental group

Treatment:

Device: ReActiv8 Implantable Stimulation System (Low Stimulation)