drugset / Trial / NCT03347929
NSAIDs in Sciatica NSAIDS IN SCIATICA
Phase 4
Completed
123 enrolled
Ostfold Hospital Trust
Helse Stavanger HF · collabOslo University Hospital · collabSykehuset Telemark · collabVestre Viken Hospital Trust · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-11-30
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
Outcome
Met primary endpoint
paper revealed a statistically significant difference in favor of naproxen, with an adjusted mean difference of -0.5 (95% CI -0.8 to -0.1, P = 0.015). PMID 38833590 ↗
Publications
- Grovle L, Hasvik E, Holst R, Saetre A, Brox JI, Mathiassen S, Myhre K, Holmgard TE, Haugen AJ. Efficacy of naproxen in patients with sciatica: multicenter, randomized, double-blind, placebo-controlled trial. Pain. 2024 Nov 1;165(11):2606-2614. doi: 10.1097/j.pain.0000000000003280. Epub 2024 Jun 4.
- Grovle L, Hasvik E, Holst R, Haugen AJ. NSAIDs in sciatica (NIS): study protocol for an investigator-initiated multicentre, randomized placebo-controlled trial of naproxen in patients with sciatica. Trials. 2022 Jun 14;23(1):493. doi: 10.1186/s13063-022-06441-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | 500 mg | Oral |