Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Northern Orthopaedic Division, Denmark

Status: Completed

Conditions: Disc Disease

Treatments: Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01499641

ON-07-011-RAS

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Epidural steroid

Active Comparator group

Description:

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

Treatment:

Drug: Methylprednisolone

None epidural steroid

Experimental group

Treatment:

Drug: Methylprednisolone