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NCT Number: NCT03347929

NSAIDs in Sciatica NSAIDS IN SCIATICA

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Revmatologisk avdeling, Sykehuset Østfold Moss, Moss, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Radiating pain below the knee with a severity score of ≥4 on a 0-10 (NRS) in the previous 24 hours
  • Signs of nerve root/spinal nerve involvement as indicated by at least one of the following features; myotomal weakness, dermatomal sensory disturbances (e.g. sensory loss, self-reported tingling/numbness), diminished reflexes, radiating pain exacerbation by SLR

Exclusion criteria

  • Not able to read or speak Norwegian.
  • Unlikely to adhere to treatment and/ or complete follow-up (e.g ongoing serious psychiatric disease, drug abuse, plans to move)
  • Sciatica of known cause other than disc herniation or degenerative stenosis.
  • Neurogenic claudication, i.e. pain in the legs on walking or standing that resolves with sitting down or lumbar flexion.
  • Symptoms indicating immediate surgery: cauda equina syndrome or a progressive large paresis.
  • Women who attempt to conceive, are pregnant or breastfeeding.
  • Previous episodes of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.
  • Active or history of peptic ulceration, gastrointestinal bleeding, or perforation.
  • Use of drugs known to increase upper gastrointestinal adverse events in combination with Naproxen: anticoagulants, aspirin (acetyl salicylic acid), serotonin reuptake inhibitors and systemic corticosteroids.
  • Hepatic enzyme (ASAT/ALAT) values above 1,5 x upper limit of normal (ULN)
  • Renal function tests (creatinin/eGFR) outside normal range
  • Congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
  • Known hypersensitivity to Naproxen or any of the excipients (lactose, maize starch, povidone, sodium starch glycolate, talcum, magnesium stearate, polysorbate 80)
  • Ongoing treatment with aspirin, systemic corticosteroids, diuretics, ACE-inhibitors, lithium and anticoagulants
  • Scheduled for spinal surgery prior to end of study
  • Reservation against intake of gelatine (the capsules contains gelatine, which among other things is produced by ingredients from pigs)

Treatment and study plan

Naproxen 500 Mg

Drug

10 days treatment with Naproxen 500 mg twice daily

Placebo

Drug

10 days treatment with Placebo1 tablet twice daily

Primary outcomes

  1. Leg pain

    Time frame: Daily from baseline to day10

    A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours

Secondary outcomes

  1. Back pain

    Time frame: Daily from baseline to day10

    24 h average back pain will be assessed by a 0-10 numeric rating scale

  2. Disability

    Time frame: Day 0, day 5, day, day 10, day 12

    Roland Morris Disability Questionnaire modified for use in sciatica

  3. Sciatica symptoms

    Time frame: Day 0, day 5, day, day 10, day 12

    Sciatica Bothersomeness Index

  4. Work

    Time frame: Day 0, day 10, day 12

    Ability to work and study as normal

  5. Improvement

    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).

  6. Rescue medication

    Time frame: Daily from day1 to day10

    Intake of Paracetamol 500 mg tablets (rescue medication) for pain

  7. Opioid medication

    Time frame: Daily from day1 to day10

    Intake of opioid medication (weak or strong) for pain

  8. Responder

    Time frame: Day 5, day 10

    >30% and >50% reduction in leg pain relative to baseline

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Helse Stavanger HF
  • Oslo University Hospital
  • Sykehuset Telemark
  • Vestre Viken Hospital Trust

Registry information

Official study title

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

Acronym: NIS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2017
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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