Clinical trial NCT02026726: Do Oral Steroid Dose Packs Predict How Well Epidural Steroid Injections Will Work?
Official title: Oral Steroid Dose Pack Used As A Predictor For The Effectiveness Of Epidural Steroid Injections
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Spine Disc Herniation
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Change in Patient-Reported Pain
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Bert L. Fichman, MD
role: PRINCIPAL_INVESTIGATOR
References: