NCT03347929

NSAIDs in Sciatica NSAIDS IN SCIATICA

NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sciatica

Interventions

Type	Name	Description
DRUG	Naproxen 500 Mg	10 days treatment with Naproxen 500 mg twice daily
DRUG	Placebo	10 days treatment with Placebo1 tablet twice daily

Timeline

• Start date: 2017-11-30
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2017-11-20
• Last updated: 2023-10-05

Locations

4 sites across 1 country: Norway