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

Lumbar Spine Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02026726
• Other study ID #: D11158
• Status: Terminated
• Start date: November 2011
• Est. completion date: August 21, 2020

Study information

• Verified date: August 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 21, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Spine Disc Herniation

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Pain	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).