Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2005-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Epidural steroid

1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Epidural methylprednisolone 40 mg or none

None epidural steroid

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

Epidural methylprednisolone 40 mg or none

Interventions

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Methylprednisolone

Epidural methylprednisolone 40 mg or none

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No