Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499641
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : September 15, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Disc Disease Drug: Methylprednisolone Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up
Study Start Date : May 2001
Actual Primary Completion Date : August 2003
Actual Study Completion Date : December 2005

Arm Intervention/treatment
Active Comparator: Epidural steroid
1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root
Drug: Methylprednisolone
Epidural methylprednisolone 40 mg or none
Experimental: None epidural steroid Drug: Methylprednisolone
Epidural methylprednisolone 40 mg or none

Primary Outcome Measures :
  1. Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Hospital stay, back and leg pain and reflex deficit. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499641

Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, Denmark, 9000
Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet
Copenhagen, Denmark
Department of Orthopaedic Surgery, Vejle and Give Hospital
Vejle, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Study Chair: Sten Rasmussen, M.D.Sci. Orthopaedic Research Unit, Aalborg University Hospital

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01499641     History of Changes
Other Study ID Numbers: ON-07-011-RAS
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
randomized control trial

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents