SciaticaPhase 4NISNCT03347929
NSAIDs in Sciatica NSAIDS IN SCIATICA
A Phase 4 study testing Naproxen 500 Mg in people with Sciatica, run by Ostfold Hospital Trust at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica
- What is being tested?
- Naproxen 500 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 4 sitesNorway
- Study dates
- 30 Nov 2017to 22 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Revmatologisk avdeling, Sykehuset Østfold Moss
Moss, 1714
Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital
Oslo, 0424
Fysikalsk medisinsk poliklinikk, Sykehuset Telemark
Porsgrunn, 3710
Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus
Stavanger, 4068
About this study
Official title: 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.
Read the 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.
- Conditions
- Sciatica
- Being tested
- Naproxen 500 Mg, Placebo
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen 500 MgDrug
10 days treatment with Naproxen 500 mg twice daily
PlaceboDrug
10 days treatment with Placebo1 tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Experimental | Naproxen 500 mg twice daily Receives: Drug: Naproxen 500 Mg |
| Placebo | Placebo comparator | Placebo 1 tablet twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg pain
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
Measured: Daily from baseline to day10
Secondary outcomes (8)
Back pain
24 h average back pain will be assessed by a 0-10 numeric rating scale
Measured: Daily from baseline to day10
Disability
Roland Morris Disability Questionnaire modified for use in sciatica
Measured: Day 0, day 5, day, day 10, day 12
Sciatica symptoms
Sciatica Bothersomeness Index
Measured: Day 0, day 5, day, day 10, day 12
Work
Ability to work and study as normal
Measured: 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).
Measured: Day 5, day 10
Rescue medication
Intake of Paracetamol 500 mg tablets (rescue medication) for pain
Measured: Daily from day1 to day10
Opioid medication
Intake of opioid medication (weak or strong) for pain
Measured: Daily from day1 to day10
Responder
>30% and >50% reduction in leg pain relative to baseline
Measured: Day 5, day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start30 Nov 2017
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Sykehuset Telemark, Helse Stavanger HF, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Waleed Ghanima, MD,PhD, Study director, Ostfold Hospital TrustAnne Haugen, MD,PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347929
- Sponsor's protocol ID
- SO-2017-1
- Other IDs
- 2014-003623-21, 2014
- Acronym
- NIS
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2017
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38833590Grovle 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.
PubMed 35701830
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen
- ClinicalTrials.gov ID
- NCT03347929
- Acronym / sponsor ID
- NIS / SO-2017-1
- Conditions
- Sciatica
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Sykehuset Telemark, Helse Stavanger HF, Oslo University Hospital
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Experimental | Drug: Naproxen 500 MgNaproxen 500 mg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tablet twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen 500 Mg10 days treatment with Naproxen 500 mg twice daily | Drug | Naproxen |
| Placebo10 days treatment with Placebo1 tablet twice daily | Drug | Placebo |
Primary outcome
Leg pain
Time frame: Daily from baseline to day10
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
8 secondary outcomes
Back pain
Time frame: Daily from baseline to day10
Disability
Time frame: Day 0, day 5, day, day 10, day 12
Sciatica symptoms
Time frame: Day 0, day 5, day, day 10, day 12
Work
Time frame: Day 0, day 10, day 12
Improvement
Time frame: Day 5, day 10
Rescue medication
Time frame: Daily from day1 to day10
Opioid medication
Time frame: Daily from day1 to day10
Responder
Time frame: Day 5, day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 38833590Grovle 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.
- Derived from this study: PubMed 35701830Grovle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Ghanima, MD,PhD study director
Ostfold Hospital Trust
Anne Haugen, MD,PhD principal investigator
Ostfold Hospital Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen 500 Mg in people with Sciatica, run by Ostfold Hospital Trust at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg pain (time frame: Daily from baseline to day10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347929, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.