NSAIDs in Sciatica NSAIDS IN SCIATICA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2023-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PF-06372865 In Subjects With Chronic Low Back Pain

NCT02262754

Chronic Low Back Pain

COMPLETED PHASE2

Effectiveness of Theramine on Chronic Back Pain

NCT01468025

Low Back Pain

COMPLETED PHASE3

A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

NCT05026320

Soft Tissue Injury

COMPLETED PHASE2

Naproxen Sodium Extended-Release Actual Use Study

NCT00751400

Pain

COMPLETED PHASE3

Self Selection Trial of Naproxen Sodium

NCT01383486

Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sciatica

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naproxen

Naproxen 500 mg twice daily

Group Type EXPERIMENTAL

Naproxen 500 Mg

Intervention Type DRUG

10 days treatment with Naproxen 500 mg twice daily

Placebo

Placebo 1 tablet twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 days treatment with Placebo1 tablet twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naproxen 500 Mg

10 days treatment with Naproxen 500 mg twice daily

Intervention Type DRUG

Placebo

10 days treatment with Placebo1 tablet twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No