Thanks [USER=43589]@BigTex[/USER]
I got my L2-L5 laminectomy 10 days ago and waiting for inflammation to go down to determine if my symptoms will get better.
Good luck!
I would not qualify due to several exclusions:
Exclusion Criteria:
To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.
Prior epidural, sacroiliac joint, or facet injections at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal)
Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty; radiofrequency (RF) ablation, spinal cord stimulator, others)
Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
Prior fracture at any lumbar level
Significant neurologic symptoms:
Grade 3/5 or lower strength in any lumbar myotome
Sensory deficit in a clearly radicular or sensory dermatome
MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab
Lumbar coronal deformity, determined by the independent radiologic central lab:
a. L1-S1 regional deformity > 25 degrees
Spondylolysis at any level
Lumbar inflammatory spondylitis
Recent history (previous six months) of chemical or alcohol dependence
Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic Perception Questionnaire (MSPQ) score > 12
Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec)
Active systemic infection
Infection at the site of procedure pre-operatively
Cauda equina syndrome or neurogenic bowel/bladder dysfunction
Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data
Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)
Any disease, condition or surgery which might impair healing, such as:
Active malignancy
History of metastatic malignancy
Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
Currently a prisoner
Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
Patient cannot be currently using the prohibited medications listed in the protocol
