Status:
UNKNOWN
A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain
Lead Sponsor:
St George Hospital, Australia
Collaborating Sponsors:
St George & Sutherland Medical Research Foundation
Conditions:
Acute Sciatica
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative effectiveness study to evaluate feasibility and to determine final sample size for a future adequately powered ra...
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03240783
Start Date
July 8 2017
End Date
October 1 2018
Last Update
August 7 2017
Active Locations (1)
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1
St George Hospital
Kogarah, New South Wales, Australia, 2217