NSAIDs in Sciatica NSAIDS IN SCIATICA

Sciatica Clinical Trial

— NIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347929
• Other study ID #: SO-2017-1
• Secondary ID: 2014-003623-21
• Status: Completed
• Phase: Phase 4
• Start date: November 30, 2017
• Est. completion date: June 22, 2023

Study information

• Verified date: July 2023
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• Naproxen 500 Mg
10 days treatment with Naproxen 500 mg twice daily
• Placebo
10 days treatment with Placebo1 tablet twice daily

Locations

Country	Name	City	State
Norway	Revmatologisk avdeling, Sykehuset Østfold Moss	Moss
Norway	Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital	Oslo
Norway	Fysikalsk medisinsk poliklinikk, Sykehuset Telemark	Porsgrunn
Norway	Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus	Stavanger

Sponsors (5)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Helse Stavanger HF, Oslo University Hospital, Sykehuset Telemark, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg pain	A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours	Daily from baseline to day10
Secondary	Back pain	24 h average back pain will be assessed by a 0-10 numeric rating scale	Daily from baseline to day10
Secondary	Disability	Roland Morris Disability Questionnaire modified for use in sciatica	Day 0, day 5, day, day 10, day 12
Secondary	Sciatica symptoms	Sciatica Bothersomeness Index	Day 0, day 5, day, day 10, day 12
Secondary	Work	Ability to work and study as normal	Day 0, day 10, day 12
Secondary	Improvement	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).	Day 5, day 10
Secondary	Rescue medication	Intake of Paracetamol 500 mg tablets (rescue medication) for pain	Daily from day1 to day10
Secondary	Opioid medication	Intake of opioid medication (weak or strong) for pain	Daily from day1 to day10
Secondary	Responder	>30% and >50% reduction in leg pain relative to baseline	Day 5, day 10