NSAIDs in Sciatica NSAIDS IN SCIATICA (NIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Sciatica
• Intervention / Treatment: Drug: Naproxen 500 Mg; Drug: Placebo

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Moss, Norway, 1714
    • Revmatologisk avdeling, Sykehuset Østfold Moss
  • Oslo, Norway, 0424
    • Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital
  • Porsgrunn, Norway, 3710
    • Fysikalsk medisinsk poliklinikk, Sykehuset Telemark
  • Stavanger, Norway, 4068
    • Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naproxen; Naproxen 500 mg twice daily	Drug: Naproxen 500 Mg; 10 days treatment with Naproxen 500 mg twice daily
Placebo Comparator: Placebo; Placebo 1 tablet twice daily	Drug: Placebo; 10 days treatment with Placebo1 tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg pain	A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours	Daily from baseline to day10

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Vestre Viken Hospital Trust; Oslo University Hospital; Helse Stavanger HF; Sykehuset Telemark
• Investigators: Study Director: Waleed Ghanima, MD,PhD, Ostfold Hospital Trust; Principal Investigator: Anne Haugen, MD,PhD, Ostfold Hospital Trust

Publications and helpful links

General Publications

• Grovle 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 Jun 14;23(1):493. doi: 10.1186/s13063-022-06441-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: SO-2017-1; 2014-003623-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No