NSAIDs in Sciatica NSAIDS IN SCIATICA
- Registration Number
- NCT03347929
- Lead Sponsor
- Ostfold Hospital Trust
- Brief Summary
This study will evaluate whether treatment with Naproxen 500 mg twice daily is superior to placebo for the improvement of leg pain in patients with sciatica. Half of patients will receive Naproxen while the other half will receive placebo.
- Detailed Description
Sciatica is an established term for pain radiating from the lower back or buttock into the leg, commonly caused by a disc herniation. Given their analgesic and anti-inflammatory mechanisms of action, NSAIDs (Non-steroidal anti-inflammatory drugs) have been, and are still being regarded as standard therapy for sciatica.
However, very few randomised controlled trials of NSAIDs have been undertaken in sciatica, and no study has showed clinically meaningful effects as compared to placebo.
Since NSAIDs involve the risk of serious gastrointestinal, vascular and renal side effects there is a strong need to clarify their potential beneficial effects in sciatica.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 1 tablet twice daily Naproxen Naproxen 500 Mg Naproxen 500 mg twice daily
- Primary Outcome Measures
Name Time Method Leg pain Daily from baseline to day10 A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
- Secondary Outcome Measures
Name Time Method Back pain Daily from baseline to day10 24 h average back pain will be assessed by a 0-10 numeric rating scale
Sciatica symptoms Day 0, day 5, day, day 10, day 12 Sciatica Bothersomeness Index
Disability Day 0, day 5, day, day 10, day 12 Roland Morris Disability Questionnaire modified for use in sciatica
Work Day 0, day 10, day 12 Ability to work and study as normal
Improvement Day 5, day 10 Global perceived change of sciatica/back problem on a verbal rating scale (Completely gone, much better, better, a little better, no change, a little worse, worse and much worse).
Opioid medication Daily from day1 to day10 Intake of opioid medication (weak or strong) for pain
Rescue medication Daily from day1 to day10 Intake of Paracetamol 500 mg tablets (rescue medication) for pain
Responder Day 5, day 10 \>30% and \>50% reduction in leg pain relative to baseline
Trial Locations
- Locations (4)
Revmatologisk avdeling, Sykehuset Østfold Moss
🇳🇴Moss, Norway
Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital
🇳🇴Oslo, Norway
Fysikalsk medisinsk poliklinikk, Sykehuset Telemark
🇳🇴Porsgrunn, Norway
Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus
🇳🇴Stavanger, Norway