Disc Disease
Conditions
Keywords
biomarker, epidural steroid, radiculopathy, hnp
Brief summary
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP
Detailed description
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.
Interventions
None listed
Sponsors
Cytonics Corporation
Scuderi, Gaetano J., M.D.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| functional outcome on SF-36 following ESI | 2-6 weeks |
Outcome results
None listed