Outcome After Lumbar Epidural Steroid Injection

Disc Disease Clinical Trial

Official title:

Functional Outcome After Lumbar Epidural Steroid Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079026
• Other study ID #: CYt.003
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: March 1, 2010
• Start date: March 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Scuderi, Gaetano J., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disc Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Scuderi, Gaetano J., M.D.	Cytonics Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome on SF-36 following ESI		2-6 weeks	No