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

Sciatica Clinical Trial

— TéAGS  

Official title:

Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816334
• Other study ID #: 1201
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2013
• Last updated: March 23, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• methylprednisolone

• Ketoprofen

• Sodium Chloride

Locations

Country	Name	City	State
France	CHU Hôpital Sud	Echirolles
France	CH d'Uriage	Uriage

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. Erratum in: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

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. Review. — View Citation

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. Epub 2007 Apr 6. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean visual analogue scale (VAS) for back pain in 3 groups	VAS is measured in millimeters (0 to 100).	From day 0 to day 5	No
Secondary	Assess drug compliance	Drug compliance is estimated based on the proportion of the treatment actually administered.	From day 0 to day 5	No
Secondary	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.	At baseline, 1 and 3 months after intervention	No
Secondary	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.	At baseline, Day 1,2,3,4 and 5 of study period	No
Secondary	Assess Schober's test	Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back	From Day 0 to Day 5	No
Secondary	Analgesic consumption	Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.	At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months	No
Secondary	Surgery or lumbar epidural injection	Number of patient having surgery and/or lumbar epidural injection during study period	At 1 and 3 months after intervention	No
Secondary	Clinical tolerance: adverse events and/or high blood pressure	Number of adverse events and/or high blood pressure between intervention group.	at baseline, day 1, 2 3, 4 and 5	No
Secondary	Biological tolerance	measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group	at baseline, day 3 and 5	No
Secondary	Glycemic levels	monitoring of glycemic status is measured for each day of treatment	at baseline, day 1 to 5	No
Secondary	Number of days of hospitalisation sick leave, number of days lost to illness	To assess the cost of sciatica for society	At baseline, 1 and 3 months	No