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Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01499641
Enrollment
200
Registered
2011-12-26
Start date
2001-05-31
Completion date
2005-12-31
Last updated
2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc Disease

Keywords

discectomy, methylprednisolone, randomized control trial

Brief summary

Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.

Detailed description

Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect. Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery. 200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.

Interventions

DRUGMethylprednisolone

Epidural methylprednisolone 40 mg or none

Sponsors

Northern Orthopaedic Division, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No

Inclusion criteria

* Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises * Patients more than 18 years old

Exclusion criteria

* Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion * Patients with cauda equina syndrome who needed acute operative treatment * Lack of informed consent and inability to read and understand Danish

Design outcomes

Primary

MeasureTime frame
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.2 years

Secondary

MeasureTime frame
Hospital stay, back and leg pain and reflex deficit.2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026