SciaticaPhase 4TéAGSNCT01816334
Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
A Phase 4 study testing methylprednisolone, Ketoprofen and Sodium Chloride in people with Sciatica, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sciatica
- What is being tested?
- methylprednisolone, Ketoprofen and Sodium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2013to Jan 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sciatica <8 weeks resistant to all treatments in ambulatory
- Acute low back pain> 48 hours;
- Non-deficit patients;
- Initial VAS> 40/100;
- Consent of patient
- Conflict disco-radicular concordance with the clinical computed tomography scan or magnetic resonance imaging.
- No of contraindications to methylprednisolone, ketoprofen;
- No registration to another protocol;
Who cannot join
- Pregnant, parturient, lactating mother;
- Diabetic patient;
- Patient with syndrome from narrowing of the lumbar vertebral canal
- Patient with a history of lumbar surgery <1 year;
- Patient with a Cauda equina syndrome or major motor disability;
- Crural neuralgia
Show all 9Show fewer
- Patient with a deficit;
- Suspicion of sciatica secondary, ie not conflict-related disco-root: infectious neuritis, fracture on spinal bone tumor ...
- associated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Hôpital Sud
Échirolles, 38130
CH d'Uriage
Uriage-les-Bains, 38410
About this study
Official title: Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
- Conditions
- Sciatica
- Being tested
- methylprednisolone, Ketoprofen, Sodium Chloride
- Keywords
- sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoprofenDrug
Sodium ChlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Active comparator | administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm Receives: Drug: methylprednisolone; Drug: Sodium Chloride |
| Ketoprofen | Active comparator | administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm Receives: Drug: Ketoprofen |
| sodium chloride | Placebo comparator | administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
Measured: From day 0 to day 5
Secondary outcomes (11)
Mean visual analogue scale (VAS) for back pain in 3 groups
VAS is measured in millimeters (0 to 100).
Measured: From day 0 to day 5
Assess drug compliance
Drug compliance is estimated based on the proportion of the treatment actually administered.
Measured: From day 0 to day 5
The effect of treatment on the EIFEL Questionnaire
The EIFEL questionnaire is the translation of the Roland Morris Disability Questionnaire (RMDQ) and has been validated in acute low back pain.
Measured: At baseline, 1 and 3 months after intervention
Improvement in Lasegue's sign compared to baseline
Lasegue's sign is the lumbar pain experienced by the patient on passive movement of the legs during flexion of hip joint i.e. passive straight leg raising. It is assessed as either 'Positive' or 'Negative' sign.
Measured: At baseline, Day 1,2,3,4 and 5 of study period
Assess Schober's test
Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back
Measured: From Day 0 to Day 5
Analgesic consumption
Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.
Measured: At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months
Surgery or lumbar epidural injection
Number of patient having surgery and/or lumbar epidural injection during study period
Measured: At 1 and 3 months after intervention
Clinical tolerance: adverse events and/or high blood pressure
Number of adverse events and/or high blood pressure between intervention group.
Measured: at baseline, day 1, 2 3, 4 and 5
Biological tolerance
measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group
Measured: at baseline, day 3 and 5
Glycemic levels
monitoring of glycemic status is measured for each day of treatment
Measured: at baseline, day 1 to 5
Number of days of hospitalisation sick leave, number of days lost to illness
To assess the cost of sciatica for society
Measured: At baseline, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816334
- Sponsor's protocol ID
- 1201
- Acronym
- TéAGS
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2013
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roncoroni C, Baillet A, Durand M, Gaudin P, Juvin R. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology (Oxford). 2011 Sep;50(9):1603-11. doi: 10.1093/rheumatology/ker151. Epub 2011 Apr 27.
PubMed 21525139Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.
PubMed 17909211Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA. Conservative treatment of sciatica: a systematic review. J Spinal Disord. 2000 Dec;13(6):463-9. doi: 10.1097/00002517-200012000-00001.
PubMed 11132976Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials. Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.
PubMed 9165992Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007 Jul;16(7):881-99. doi: 10.1007/s00586-007-0367-1. Epub 2007 Apr 6.
PubMed 17415595
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
- ClinicalTrials.gov ID
- NCT01816334
- Acronym / sponsor ID
- TéAGS / 1201
- Conditions
- Sciatica
- Keywords
- sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Mar 2013 (estimated)
- 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.
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Active comparator | Drug: methylprednisolone, Drug: Sodium Chlorideadministration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm |
| Ketoprofen | Active comparator | Drug: Ketoprofenadministration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm |
| sodium chloride | Placebo comparator | Drug: Sodium Chlorideadministration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- sciatica <8 weeks resistant to all treatments in ambulatory
- Acute low back pain> 48 hours;
- Non-deficit patients;
- Initial VAS> 40/100;
- Consent of patient
Key exclusion criteria (9 listed)
- Pregnant, parturient, lactating mother;
- Diabetic patient;
- Patient with syndrome from narrowing of the lumbar vertebral canal
- Patient with a history of lumbar surgery <1 year;
- Patient with a Cauda equina syndrome or major motor disability;
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 |
|---|---|---|
| methylprednisolone | Drug | methylprednisolone |
| Ketoprofen | Drug | Ketoprofen |
| Sodium Chloride | Drug | methylprednisolone, sodium chloride |
Primary outcome
Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
Time frame: From day 0 to day 5
VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
11 secondary outcomes
Mean visual analogue scale (VAS) for back pain in 3 groups
Time frame: From day 0 to day 5
Assess drug compliance
Time frame: From day 0 to day 5
The effect of treatment on the EIFEL Questionnaire
Time frame: At baseline, 1 and 3 months after intervention
Improvement in Lasegue's sign compared to baseline
Time frame: At baseline, Day 1,2,3,4 and 5 of study period
Assess Schober's test
Time frame: From Day 0 to Day 5
Analgesic consumption
Time frame: At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months
Surgery or lumbar epidural injection
Time frame: At 1 and 3 months after intervention
Clinical tolerance: adverse events and/or high blood pressure
Time frame: at baseline, day 1, 2 3, 4 and 5
Biological tolerance
Time frame: at baseline, day 3 and 5
Glycemic levels
Time frame: at baseline, day 1 to 5
Number of days of hospitalisation sick leave, number of days lost to illness
Time frame: At baseline, 1 and 3 months
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 24 Mar 2016.
- Background: PubMed 21525139Roncoroni C, Baillet A, Durand M, Gaudin P, Juvin R. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology (Oxford). 2011 Sep;50(9):1603-11. doi: 10.1093/rheumatology/ker151. Epub 2011 Apr 27.
- Background: PubMed 17909211Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.
- Background: PubMed 11132976Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA. Conservative treatment of sciatica: a systematic review. J Spinal Disord. 2000 Dec;13(6):463-9. doi: 10.1097/00002517-200012000-00001.
- Background: PubMed 9165992Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials. Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.
- Background: PubMed 17415595Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007 Jul;16(7):881-99. doi: 10.1007/s00586-007-0367-1. Epub 2007 Apr 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 methylprednisolone, Ketoprofen and Sodium Chloride in people with Sciatica, run by University Hospital, Grenoble at 2 sites in France.
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 8 inclusion and 9 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups (time frame: From day 0 to day 5). 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 NCT01816334, which also lists 5 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 24 Mar 2016.