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Outcome After Lumbar Epidural Steroid Injection

S

Scuderi, Gaetano J., M.D.

Status

Completed

Conditions

Disc Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01079026
CYt.003

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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