Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The condition is caused by injury to or compression of the sciatic nerve, which is located in the back of the leg. This study will determine the effectiveness of the steroid prednisone in decreasing pain and improving function in people with sciatica.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site

• Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution

• Score of at least 20 on the modified Oswestry Disability Index

• Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc

• MRI study confirms a herniated disc consistent with the signs and symptoms

Exclusion Criteria:

• Onset of sciatica symptoms occurred more than 3 months before study entry

• Cauda equina syndrome

• Active cancer

• Acute spinal fracture

• Currently taking oral steroids

• Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%

• Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg

• Pregnant or breastfeeding

• Active peptic ulcer disease

• History of intolerance to steroid therapy

• Bleeding diathesis or anticoagulant therapy

• Ongoing litigation or workers compensation claim for low back pain or sciatica

• Underwent previous lumbar surgery

• Received epidural steroid injection (ESI) within the 12 months before study entry

• Unable to read or speak English

• Progressive or severe motor loss