NSAIDs in Sciatica NSAIDS IN SCIATICA

NCT03347929 | Completed Phase 4

• 2 other identifiers: SO-2017-12014-003623-21
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 4

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 while the other half will receive placebo.

Conditions

Sciatica

Outcome Measures

Primary Outcomes (1)

• Leg pain

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

  Daily from baseline to day10

Secondary Outcomes (8)

• Back pain

  Daily from baseline to day10

• Disability

  Day 0, day 5, day, day 10, day 12

• Sciatica symptoms

  Day 0, day 5, day, day 10, day 12

• Work

  Day 0, day 10, day 12

• Improvement

  Day 5, day 10

Study Arms (2)

Naproxen

EXPERIMENTAL

Naproxen 500 mg twice daily

Drug: Naproxen 500 Mg

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet twice daily

Drug: Placebo

Interventions

Naproxen 500 Mg DRUG

10 days treatment with Naproxen 500 mg twice daily

Naproxen

Placebo DRUG

10 days treatment with Placebo1 tablet twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Vestre Viken Hospital Trust: collaborator
• Sykehuset Telemark: collaborator
• Helse Stavanger HF: collaborator
• Oslo University Hospital: collaborator

Study Sites (4)

Revmatologisk avdeling, Sykehuset Østfold Moss

Moss, 1714, Norway

Location

Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital

Oslo, 0424, Norway

Location

Fysikalsk medisinsk poliklinikk, Sykehuset Telemark

Porsgrunn, 3710, Norway

Location

Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus

Stavanger, 4068, Norway

Location

Related Publications (2)

• Grovle L, Hasvik E, Holst R, Saetre A, Brox JI, Mathiassen S, Myhre K, Holmgard TE, Haugen AJ. Efficacy of naproxen in patients with sciatica: multicenter, randomized, double-blind, placebo-controlled trial. Pain. 2024 Nov 1;165(11):2606-2614. doi: 10.1097/j.pain.0000000000003280. Epub 2024 Jun 4.

  PMID: 38833590 DERIVED

• 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.

  PMID: 35701830 DERIVED

MeSH Terms

Conditions

Sciatica

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Waleed Ghanima, MD,PhD

  Ostfold Hospital Trust

  STUDY DIRECTOR

• Anne Haugen, MD,PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: November 20, 2017
• Study Start: November 30, 2017
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)