NSAIDs in Sciatica NSAIDS IN SCIATICA
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.
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.
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)