Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Northern Orthopaedic Division, Denmark200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Disc Disease

Interventions

MethylprednisoloneDRUG

Epidural methylprednisolone 40 mg or none

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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

Locations (3)

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, Denmark

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Hospital stay, back and leg pain and reflex deficit.

Time frame: 2 years

Data from ClinicalTrials.gov

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