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

August 21, 2020 updated by: Bert L. Fichman, Dartmouth-Hitchcock Medical Center

Oral Steroid Dose Pack Used As A Predictor For The Effectiveness Of Epidural Steroid Injections

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Reported Pain
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Bert L. Fichman, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 21, 2020

Study Completion (Actual)

August 21, 2020

Study Registration Dates

First Submitted

December 30, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D11158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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