Background & Aims

Despite the widespread use of non-steroidal anti-inflammatory drugs (NSAIDs) for the symptomatic treatment of sciatica, their potential benefits remain uncertain. The aim of this study was to assess the efficacy of naproxen in patients with sciatica.

Methods

We used a multicenter, two-armed parallel, randomized, placebo-controlled, double-blind trial. We included patients with radiating pain below the knee (? 4 on a 0–10 numeric rating scale) and signs consistent with nerve root involvement. The intervention was naproxen 500 mg, or a placebo, twice daily for 10 days.

The primary outcome was daily measurements of leg pain intensity scored on a 0–10 numeric rating scale measured throughout the treatment period. Secondary outcomes included ? 30%, and ? 50% improvement in leg pain scores, back pain intensity (0-10), Roland Morris Disability Questionnaire for Sciatica (RMDQ-S, 0–23) (1), the Sciatica Bothersomeness Index (2), consumption of rescue medication (Paracetamol), concomitant use of opioids, self-reported ability to work or study, and global perceived change of sciatica/back problem.

The protocol is registered at ClinicalTrials.gov under the number NCT03347929, along with a statistical analysis plan (3).

Results

A statistically significant difference favoring naproxen was detected in leg pain scores, with an adjusted mean difference of ?0.5 (95% CI ?0.8 to ?0.1, p = 0.015). In the naproxen group, the treatment effect was significantly related to time, and over the whole 10-day period, the average adjusted difference was ?0.6 (95% CI ?0.8 to ?0.5). Mean numbers needed to treat for 30% improvement were 9.9 (95% CI 4.7 to 15.0), and for 50% improvement, 20.7 (8.7 to 32.7). The adjusted mean difference for back pain was ?0.4 (95% CI ?0.8 to 0.0), and for RMDQ-S, ?1.5 (?3.0 to 0.0). No differences were found for sciatica bothersomeness or consumption of rescue medication or weak opioids. No participants used strong opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3 to 16.2) for improvement by one level on the global perceived change scale. No serious adverse events were recorded.

Conclusions

In comparison to placebo, ten days of Naproxen treatment yielded modest, clinically insignificant benefits for patients with moderate to severe sciatica.

References

1. Grøvle 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;23(1):493.

2. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine (Phila Pa 1976) 1995;20(17):1899-1908; discussion 1909.

3. Grøvle L, Haugen AJ, Keller A, Natvig B, Brox JI, Grotle M. Reliability, validity, and responsiveness of the Norwegian versions of the Maine-Seattle Back Questionnaire and the Sciatica Bothersomeness and Frequency Indices. Spine (Phila Pa 1976) 2008;33(21):2347-2353.

Presenting Author

Eivind Hasvik

Poster Authors

Eivind Hasvik

PT BSc, MSc, PhD

Østfold Hospital Trust

Lead Author

Lars Grøvle

MD

Østfold Hospital Trust

Lead Author

René Holst

PhD

University of Oslo, Østfold Hospital Trust

Lead Author

Anders Sætre

MD

Telemark Hospital Trust

Lead Author

Jens Ivar Brox

MD

Oslo University Hospital, University of Oslo

Lead Author

Ståle Mathiassen

MD

Stavanger University Hospital

Lead Author

Kjersti Myhre

MD

kjersti.myhre@medisin.uio.no

Lead Author

Thor Einar Holmgard

Lead Author

Anne Julsrud Haugen

Østfold Hospital Trust

Lead Author

Topics

  • Evidence, Clinical Trials, Systematic Review, Guidelines, and Implementation Science