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NSAIDs in Sciatica NSAIDS IN SCIATICA (NIS)

Primary Purpose

Sciatica

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Naproxen 500 Mg
Placebo
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Revmatologisk avdeling, Sykehuset Østfold Moss
  • Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital
  • Fysikalsk medisinsk poliklinikk, Sykehuset Telemark
  • Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naproxen

Placebo

Arm Description

Naproxen 500 mg twice daily

Placebo 1 tablet twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2017
Last Updated
October 2, 2023
Sponsor
Ostfold Hospital Trust
Collaborators
Vestre Viken Hospital Trust, Sykehuset Telemark, Helse Stavanger HF, Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03347929
Brief Title
NSAIDs in Sciatica NSAIDS IN SCIATICA
Acronym
NIS
Official Title
NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Vestre Viken Hospital Trust, Sykehuset Telemark, Helse Stavanger HF, Oslo University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naproxen
Arm Type
Experimental
Arm Description
Naproxen 500 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Naproxen 500 Mg
Intervention Description
10 days treatment with Naproxen 500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 days treatment with Placebo1 tablet twice daily
Primary Outcome Measure Information:
Title
Leg pain
Description
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
Time Frame
Daily from baseline to day10
Secondary Outcome Measure Information:
Title
Back pain
Description
24 h average back pain will be assessed by a 0-10 numeric rating scale
Time Frame
Daily from baseline to day10
Title
Disability
Description
Roland Morris Disability Questionnaire modified for use in sciatica
Time Frame
Day 0, day 5, day, day 10, day 12
Title
Sciatica symptoms
Description
Sciatica Bothersomeness Index
Time Frame
Day 0, day 5, day, day 10, day 12
Title
Work
Description
Ability to work and study as normal
Time Frame
Day 0, day 10, day 12
Title
Improvement
Description
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).
Time Frame
Day 5, day 10
Title
Rescue medication
Description
Intake of Paracetamol 500 mg tablets (rescue medication) for pain
Time Frame
Daily from day1 to day10
Title
Opioid medication
Description
Intake of opioid medication (weak or strong) for pain
Time Frame
Daily from day1 to day10
Title
Responder
Description
>30% and >50% reduction in leg pain relative to baseline
Time Frame
Day 5, day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed Ghanima, MD,PhD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne Haugen, MD,PhD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revmatologisk avdeling, Sykehuset Østfold Moss
City
Moss
ZIP/Postal Code
1714
Country
Norway
Facility Name
Avdeling for fysikalsk medisin og rehabilitering, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Fysikalsk medisinsk poliklinikk, Sykehuset Telemark
City
Porsgrunn
ZIP/Postal Code
3710
Country
Norway
Facility Name
Avdeling for fysikalsk medisin og rehabilitering, Stavanger Universitetssjukehus
City
Stavanger
ZIP/Postal Code
4068
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35701830
Citation
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.
Results Reference
derived

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NSAIDs in Sciatica NSAIDS IN SCIATICA

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