Do Oral Steroid Dose Packs Predict How Well Epidural Steroid Injections Will Work?
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02026726
Recruitment Status :
(could not recruit)
First Posted : January 3, 2014
Last Update Posted : August 25, 2020
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Bert L. Fichman, Dartmouth-Hitchcock Medical Center
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients that had magnetic resonance imaging (MRI) documented lumbar herniated discs with unilateral radicular symptoms that correlated to their physical exam and MRI findings.
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
Prior lumbar surgery
Cauda equina syndrome
Spine infection or tumor
Severe motor deficit
Cardiac or pulmonary comorbid conditions contraindicating interventional procedures