ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pai

Completed

Conditions: low back pain for at least 3 months
pain at back below
10028302
10041543
10009720

Registration Number: NL-OMON45928

Lead Sponsor: MML US Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Age *22 years, *65 years
2. 7 day recall of Average Low Back Pain (VAS of *6.0cm and *9.0cm at baseline)
3. Oswestry Disability Index score *21% and *60% at the Baseline Visit.
4. Chronic Low Back Pain defined as pain and discomfort localized below the costal margin
and above the inferior gluteal fold (with or without referred leg pain) that has persisted >90
days prior to the baseline visit, which has resulted in pain in at least half of the days in the 12 months prior to the baseline visit.
5. Evidence of lumbar multifidus muscle dysfunction by the Prone Instability Test (PIT).
6. Continuing low back pain despite >90 days medical management including:
a. At least one attempt of physical therapy treatment
b. For Subjects with medications prescribed and used for chronic low back pain, usage
shall be at a stable dose in the 30 days prior to the baseline visit
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:
a. Any surgical correction procedure for scoliosis, or a current clinical
diagnosis of moderate to severe scoliosis.
b. Lumbar spine stenosis,
c. Neurological deficit possibly associated with the back pain.
d. Back pain due to pelvic or visceral reasons or infection.
e. Back pain due to inflammation or damage to the spinal cord or adjacent structures
f. Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amendable to surgery.
g. Back pain due to vascular causes such as aortic aneurysm and dissection.
3. Leg pain described as being worse than back pain, or radiculopathy below the knee.
4. Source of pain is the sacroiliac joint.
5. Certain surgical or other procedures exclusions (please refer to the protocol):
6. Planned surgery:
7. Pregnant or planning to be pregnant in the next 12 months.
8. Any other active implantable device
9. Prior exposure to an implantable neurostimulator for treatment of pain

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Efficacy Endpoint is a comparison of responder rates between<br /><br>Treatment and Control groups, where a responder is a Subject with *30%<br /><br>reduction from baseline in average low back pain without any increase in pain<br /><br>medication and/or muscle relaxants prescribed and taken in the two weeks prior<br /><br>to the primary outcome assessment visit.<br /><br><br /><br>The primary safety assessment is serious device and/or procedure related<br /><br>adverse events in all subjects in the Intent to Treat Cohort at the primary<br /><br>Endpoint Assessment visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy objectives:<br /><br>1. Comparison of change in ODI between Treatment and Control groups at the<br /><br>Primary End Point Assessment Visit.<br /><br>2. Comparison of change in EQ-5D between Treatment and Control groups at the<br /><br>Primary End Point Assessment Visit<br /><br>3. Comparison of Percent Pain Relief between Treatment and Control groups<br /><br>reported by the Subject at the Primary End Point Assessment Visit<br /><br>4. Comparison of Subject Global Impression of Change at the Primary End Point<br /><br>Assessment Visit<br /><br>5. Comparison of number of subjects with Resolution of Low Back Pain (remitters<br /><br>or cure) at the Primary End Point Assessment Visit<br /><br>6. Evaluation of changes in primary and secondary efficacy metrics in Crossover<br /><br>Group following the Outcome Post Crossover visit.</p><br>