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

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02026726
Collaborator
(none)
10
Enrollment
1
Location
105.7
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Oral Steroid Dose Pack Used As A Predictor For The Effectiveness Of Epidural Steroid Injections
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Aug 21, 2020
    Actual Study Completion Date :
    Aug 21, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change in Patient-Reported Pain [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bert L. Fichman, Staff Physician, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT02026726
    Other Study ID Numbers:
    • D11158
    First Posted:
    Jan 3, 2014
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Intervertebral Disc Displacement

    Study Results

    No Results Posted as of Aug 25, 2020