A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain

Launched by ST GEORGE HOSPITAL, AUSTRALIA · Aug 1, 2017

Keywords

ClinConnect Summary

Acute sciatica, a major cause of pain and disability, is a common presentation to medical practices and hospitals. Up to 25% of patients do not recover after 12 months. Sciatica refers to radicular pain and radiculopathy from lumbosacral nerve root pathology caused by lumbosacral disc herniation and degenerative lumbosacral spondylosis involving the L2/3 to L5/S1 intervertebral discs and foramina. Selective transforaminal epidural steroid injection and systemic steroids are therapeutic options in patients who do not improve with conservative management. However, there is limited evidence of...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Leg pain of any description with clinical findings consistent with single level radiculopathy
• • Minimum symptom duration \> 72hrs
• • Maximum symptom duration \< 3 weeks to ensure symptom duration at randomisation is ≤ 4 weeks
• • No previous episode of same level radicular pain in the previous 6 months
• • Pain intensity at \>30 on the Oswestry Disability Index (ODI)
• • Imaging (MRI and/or CT) indicating herniated disc or foraminal stenosis or both, concordant with the level indicated by history and physical examination
• Exclusion Criteria:
• • Previous transforaminal epidural steroids at any level in the last 12 months
• • Previous oral steroids in the last 12 months
• • Any lumbar surgery at same level, or above or below the level at any time
• • Previous lumbar surgery at any other level to that in (iii) within the last 12 months
• • Pregnancy, or lactation/breastfeeding
• • Direct indication for neurosurgery (e.g. cauda equina syndrome, or progressive motor loss i.e. less than or equal to 3/5 power)
• • Inability to read or understand English
• • Any serious medical or psychiatric condition that may interfere with participation or outcome assessment such as: need for uninterrupted anti-coagulation, spinal fracture, active infection or metastatic disease suspected, active cancer, poorly controlled diabetes, or patients with diabetes on any insulin, uncontrolled hypertension (systolic blood pressure \>180 or diastolic blood pressure \>110 within 30 days of randomization date), active peptic ulcer disease, history of intolerance to steroid therapy, previous or current psychiatric history of bipolar disease, or secondary gain such as anticipated or ongoing legal proceedings, history of substance abuse