Naproxen 500 Mg
Drug10 days treatment with Naproxen 500 mg twice daily
NCT Number: NCT03347929
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Revmatologisk avdeling, Sykehuset Østfold Moss, Moss, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 days treatment with Naproxen 500 mg twice daily
10 days treatment with Placebo1 tablet twice daily
Time frame: Daily from baseline to day10
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
Time frame: Daily from baseline to day10
24 h average back pain will be assessed by a 0-10 numeric rating scale
Time frame: Day 0, day 5, day, day 10, day 12
Roland Morris Disability Questionnaire modified for use in sciatica
Time frame: Day 0, day 5, day, day 10, day 12
Sciatica Bothersomeness Index
Time frame: Day 0, day 10, day 12
Ability to work and study as normal
Time frame: 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).
Time frame: Daily from day1 to day10
Intake of Paracetamol 500 mg tablets (rescue medication) for pain
Time frame: Daily from day1 to day10
Intake of opioid medication (weak or strong) for pain
Time frame: Day 5, day 10
>30% and >50% reduction in leg pain relative to baseline
Ostfold Hospital Trust
Other
NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen
Acronym: NIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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