Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01499641
First received: December 13, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Disc Disease
Drug: Methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital stay, back and leg pain and reflex deficit. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: May 2001
Study Completion Date: December 2005
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499641

Locations
Denmark
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
Investigators
Study Chair: Sten Rasmussen, M.D.Sci. Orthopaedic Research Unit, Aalborg University Hospital
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01499641     History of Changes
Other Study ID Numbers: ON-07-011-RAS
Study First Received: December 13, 2011
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on August 28, 2014