Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499641
• Other study ID #: ON-07-011-RAS
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: September 12, 2014
• Start date: May 2001
• Est. completion date: December 2005

Study information

• Verified date: September 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disc Disease

Intervention

Drug:
• Methylprednisolone
Epidural methylprednisolone 40 mg or none

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Aalborg
Denmark	Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet	Copenhagen
Denmark	Department of Orthopaedic Surgery, Vejle and Give Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.		2 years	Yes
Secondary	Hospital stay, back and leg pain and reflex deficit.		2 years	Yes