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OpenTrials
Completed

NCT Number: NCT01079026

Outcome After Lumbar Epidural Steroid Injection

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. functional outcome on SF-36 following ESI

    Time frame: 2-6 weeks

Sponsors and collaborators

Lead sponsor

Scuderi, Gaetano J., M.D.

Other

Collaborators

  • Cytonics Corporation

Registry information

Official study title

Functional Outcome After Lumbar Epidural Steroid Injection

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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