Outcome After Lumbar Epidural Steroid Injection

NCT01079026 | Completed DMC

• 1 other identifier: CYt.003
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Disc Disease

Keywords

biomarker; epidural steroid; radiculopathy; hnp

Outcome Measures

Primary Outcomes (1)

• functional outcome on SF-36 following ESI

  2-6 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scuderi, Gaetano J., M.D.: lead
• Cytonics Corporation: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

lavage fluid from epidural space

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gaetano J Scuderi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2010-03