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Status:

COMPLETED

NSAIDs in Sciatica NSAIDS IN SCIATICA

Lead Sponsor:

Ostfold Hospital Trust

Collaborating Sponsors:

Vestre Viken Hospital Trust

Sykehuset Telemark

Conditions:

Sciatica

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 whi...

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, ...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    November 30 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 22 2023

    Estimated Enrollment :

    123 Patients enrolled

    Trial Details

    Trial ID

    NCT03347929

    Start Date

    November 30 2017

    End Date

    June 22 2023

    Last Update

    October 5 2023

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Revmatologisk avdeling, Sykehuset Østfold Moss

    Moss, Norway, 1714

    2

    Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital

    Oslo, Norway, 0424

    3

    Fysikalsk medisinsk poliklinikk, Sykehuset Telemark

    Porsgrunn, Norway, 3710

    4

    Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus

    Stavanger, Norway, 4068