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

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ClinicalTrials.gov Identifier: NCT02026726
Recruitment Status : Terminated (could not recruit)
First Posted : January 3, 2014
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bert L. Fichman, Dartmouth-Hitchcock Medical Center

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
Lumbar Spine Disc Herniation

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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 : November 2011
Actual Primary Completion Date : August 21, 2020
Actual Study Completion Date : August 21, 2020



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026726


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Bert L. Fichman, MD Dartmouth-Hitchcock Medical Center
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Responsible Party: Bert L. Fichman, Staff Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02026726    
Other Study ID Numbers: D11158
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical