Reduction of Pain and Symptoms Following Lumbar Surgery Study
This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded clinical study to assess the safety and effectiveness for the reduction of pain and symptoms following lumbar surgery.
In order to participate you must meet the following criteria:
- Are between 22 and 70 years of age.
- Have symptomatic posterior or posterolateral disc herniation at L4-L5 or L5-S1 with radiographic confirmation of nerve compression using MRI that requires partial surgical discectomy with or without laminotomy.
- Have radiculopathy (e.g., decreased motor strength, sensory deficits, decreased reflexes) from specific nerve root distribution from L4 to S1 with positive straight leg raise (0-60 degrees).
- Have at least one of the following:
- Have had at least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications, narcotics, and muscle relaxants at the manufacturer's recommended therapeutic dose).
- Are experiencing intractable pain.
- Have substantial progression of loss of neurological function.
You will be excluded from the study if any of the following criteria apply to you:
- Have radiographic confirmation (via MRI) of severe facet disease or facet degeneration at the index lumbar level.
- Have had prior spine surgery at any lumbar level.
- Require spinal surgery other than a partial discectomy (with or without laminotomy) to treat leg/back pain (osteophyte removal is allowed).
- Have had previous trauma to the lumbar spine resulting in fracture or documented ligament injury.
This is a partial list of inclusion and exclusion criteria.