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Completed

NCT Number: NCT01499641

Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

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

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Key information

Conditions

Disc Disease

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

Epidural methylprednisolone 40 mg or none

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Hospital stay, back and leg pain and reflex deficit.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2005
First posted
Dec 26, 2011
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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