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

NCT01816334 | Completed Phase 4 DMC

• 1 other identifier: 1201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sciatica

Keywords

sciatica; Anti-Inflammatory Agents, Non-Steroidal; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• 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.

  From day 0 to day 5

Secondary Outcomes (11)

• Mean visual analogue scale (VAS) for back pain in 3 groups

  From day 0 to day 5

• Assess drug compliance

  From day 0 to day 5

• The effect of treatment on the EIFEL Questionnaire

  At baseline, 1 and 3 months after intervention

• Improvement in Lasegue's sign compared to baseline

  At baseline, Day 1,2,3,4 and 5 of study period

• Assess Schober's test

  From Day 0 to Day 5

Study Arms (3)

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

Drug: methylprednisolone; Drug: Sodium Chloride

Ketoprofen

ACTIVE COMPARATOR

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

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

Drug: Sodium Chloride

Interventions

methylprednisolone DRUG

methylprednisolone

Ketoprofen DRUG

Ketoprofen

Sodium Chloride DRUG

methylprednisolone; sodium chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

CHU Hôpital Sud

Échirolles, 38130, France

Location

CH d'Uriage

Uriage-les-Bains, 38410, France

Location

Related Publications (5)

• 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.

  PMID: 21525139 BACKGROUND

• 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.

  PMID: 17909211 BACKGROUND

• 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.

  PMID: 11132976 BACKGROUND

• 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.

  PMID: 9165992 BACKGROUND

• 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.

  PMID: 17415595 BACKGROUND

MeSH Terms

Conditions

Sciatica

Interventions

Methylprednisolone; Ketoprofen; Sodium Chloride

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 22, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

FR (2)