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

MML US Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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.

•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

发起方

MML US Inc.