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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003623-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Vestre Viken Hospital Trust | OTHER |
| Sykehuset Telemark | OTHER_GOV |
| Helse Stavanger HF | OTHER_GOV |
| Oslo University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen | Experimental | Naproxen 500 mg twice daily |
|
| Placebo | Placebo Comparator | Placebo 1 tablet twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen 500 Mg | Drug | 10 days treatment with Naproxen 500 mg twice daily |
| |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waleed Ghanima, MD,PhD | Ostfold Hospital Trust | Study Director |
| Anne Haugen, MD,PhD | Ostfold Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Revmatologisk avdeling, Sykehuset Østfold Moss | Moss | 1714 | Norway | |||
| Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833590 | Derived | 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. | |
| 35701830 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2022 | Feb 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2023 | Sep 30, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| OTHER |
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| Placebo |
| Drug |
10 days treatment with Placebo1 tablet twice daily |
|
| 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 |
| Oslo |
| 0424 |
| Norway |
| Fysikalsk medisinsk poliklinikk, Sykehuset Telemark | Porsgrunn | 3710 | Norway |
| Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus | Stavanger | 4068 | Norway |
| 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. |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |