Outcome After Lumbar Epidural Steroid Injection (NCT01079026)

Study summary

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

Read the 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.

Conditions studied

Disc Disease

Keywords

biomarker
epidural steroid
radiculopathy
hnp

In context

Lead sponsor

Scuderi, Gaetano J., M.D. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No
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.

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

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
Enrollment: 26 participants (actual)
Biospecimen retention: Samples with dna

What researchers measure

Primary outcomes

functional outcome on SF-36 following ESI
Time frame: 2-6 weeks

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01079026
Lead sponsor: Scuderi, Gaetano J., M.D.
Collaborators: Cytonics Corporation
First posted: Mar 2, 2010
Start date: Mar 2008
Primary completion: Mar 2010
Completion: Mar 2010
Last update: Mar 2, 2010

Study contacts

Gaetano J Scuderi, MD

principal investigator · Stanford University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Outcome After Lumbar Epidural Steroid Injection