prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP

We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.

Inclusion Criteria:

• Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions
• Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND
• MRI of lumbar spine positive for HNP in a distribution correlating with physical examination

Exclusion Criteria:

• Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I
• A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5)
• Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND
• Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases

Patients considered candidates for ESI were 18 years of age or greater with a history of leg sensory complaints primarily dictated by pain with associated sensory symptoms and/or low back pain for two weeks or more who had failed expectant management with NSAIDS, activity modification, and/or physical therapy.