Phase 2 N=269 Randomized Triple-blind Treatment

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

Sciatica

Bottom Line

View on ClinicalTrials.gov: NCT00668434 ↗

Enrolled (actual)

269

Serious AEs

1.9%

Results posted

Apr 2015

Primary outcome: Primary: Oswestry Disability Index, v2 — -19.0; -13.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Prednisone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Oswestry Disability Index, v2	-37.8; -30.4	—
SECONDARY Pain Numerical Rating Scale	-5.2; -4.6	—
SECONDARY Oswestry Disability Index, v2	-37.8; -30.4	—
SECONDARY Pain Numerical Rating Scale	-5.2; -4.6	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00668434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.