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

NCT ID: NCT02026726

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2020-08-21

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.

Conditions

Lumbar Spine Disc Herniation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bert L. Fichman

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bert L. Fichman, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D11158

Identifier Type: -

Identifier Source: org_study_id