Status:
COMPLETED
Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Sciatica
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 l...
Detailed Description
Sciatica is most often caused by a herniated disc in the lumbar region of the back and results from inflammation of the nerve roots as they exit the spine. It is a very common cause of back and leg pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00668434
Start Date
November 1 2008
End Date
September 1 2013
Last Update
April 28 2015
Active Locations (3)
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1
Kaiser Permanente Northern California, Redwood City
Redwood City, California, United States, 94063
2
Kaiser Permanente
Roseville, California, United States, 95661
3
Kaiser Permanente Northern California, San Jose
San Jose, California, United States, 94119