Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica

NCT ID: NCT01816334

Last Updated: 2016-03-24

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica

Detailed Description

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Conditions

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Sciatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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methylprednisolone

administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

Sodium Chloride

Intervention Type DRUG

Ketoprofen

administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm

Group Type ACTIVE_COMPARATOR

Ketoprofen

Intervention Type DRUG

sodium chloride

administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm

Group Type PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type DRUG

Interventions

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methylprednisolone

Intervention Type DRUG

Ketoprofen

Intervention Type DRUG

Sodium Chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Hôpital Sud

Échirolles, , France

Site Status

CH d'Uriage

Uriage-les-Bains, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21525139 (View on PubMed)

Chou 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.

Reference Type BACKGROUND
PMID: 17909211 (View on PubMed)

Vroomen 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.

Reference Type BACKGROUND
PMID: 11132976 (View on PubMed)

Koes 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.

Reference Type BACKGROUND
PMID: 9165992 (View on PubMed)

Luijsterburg 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.

Reference Type BACKGROUND
PMID: 17415595 (View on PubMed)

Other Identifiers

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1201

Identifier Type: -

Identifier Source: org_study_id

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