Do Oral Steroid Dose Packs Predict How Well Epidural Steroid Injections Will Work?

NCT02026726 | Terminated

• 1 other identifier: D11158
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to show whether a standard oral steroid dose pack can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid injection (ESI). If an oral steroid does not give a patient significant temporary relief of pain from a herniated lumbar disc then an epidural steroid injection will not either. Therefore the risk and expense associated from the interventional pain management procedure for those patients could be avoided and other treatment modalities pursued.

Conditions

Lumbar Spine Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Pain

  The primary endpoint will be a patient-reported pain as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being the most severe pain imaginable.

  Baseline,1 wk post oral steroid completion, 2 wks post ESI #1, 2 wks post ESI #2, 2 wks post ESI #3, then at 6 wks, 12 wks, 6 mo. & 12 mo. after last transforaminal ESI (TRESI).

Eligibility Criteria

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

Study Population

Patients that had magnetic resonance imaging (MRI) documented lumbar herniated discs with unilateral radicular symptoms that correlated to their physical exam and MRI findings.

You may qualify if:

• years and older
• Diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms with or without some nonoperative treatment for at least 4 weeks
• Radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations)
• Evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise-positive between 30° and 70°) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution)
• Undergone either MRI or CT scan showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms
• Patients with multiple herniations can be included if only one of the herniations is considered symptomatic
• Preenrollment nonprocedural care can include: education/counseling, physical therapy, chiropractic therapy, anti-inflammatory medications, opioid analgesics, adjuvant analgesics such as anticonvulsants and antidepressants

You may not qualify if:

• Prior lumbar surgery
• Cauda equina syndrome
• Vertebral fractures
• Spine infection or tumor
• Severe motor deficit
• Inflammatory spondyloarthropathy
• Pregnancy
• Cardiac or pulmonary comorbid conditions contraindicating interventional procedures
• Diabetes
• Inability/unwillingness to have spinal injections

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Officials

• Bert L. Fichman, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 3, 2014
• Study Start: November 1, 2011
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

US (1)