ReActiv8 for Chronic Low Back Pain (PMCF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.

Official Title
-----------------
Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: ReActiv8 Implantable Stimulation System implanted and activated.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReActiv8 Implant<br> | Device: ReActiv8 Implantable Stimulation System implanted and activated.<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11 Point Numerical Rating Scale (NRS) for Low Back Pain |  | 90 days | 
| Number of subjects with Adverse Events |  | 90 days, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | 90 days |