Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Not Applicable

Completed

• Conditions: Disc Disease
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT01499641
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2003-08
• Study Completion: 2005-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
None epidural steroid	Methylprednisolone	-
Epidural steroid	Methylprednisolone	1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root

Primary Outcome Measures

Name	Time	Method
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.	2 years

Secondary Outcome Measures

Name	Time	Method
Hospital stay, back and leg pain and reflex deficit.	2 years

Trial Locations

Locations (3)

Department of Orthopaedic Surgery, Vejle and Give Hospital; 🇩🇰 Vejle, Denmark

Orthopaedic Surgery Research Unit, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet; 🇩🇰 Copenhagen, Denmark