The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis

Spinal Stenosis of Lumbar Region Clinical Trial

Official title:

A Prospective Controlled Study Randomized Double Blind Study, Evaluate the Effectiveness of Oral Corticosteroids in the Treatment of Stenosis of Lumbar Canal In Symptomatic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01456377
• Other study ID #: 1892/10
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2011
• Last updated: October 19, 2011
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2011
• Source: Federal University of São Paulo
• Contact: Luiz Claudio l Rodrigues, doctor
• Phone: 551120706317
• Email: luizclr[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.

Description:

60 patients are being randomized, plank by randomization, the patient and the examiner will be blinded. Will be placed in opaque brown envelopes in order to maintain the secrecy of allocation.

Included patients aged between 50 and 75 years of both sexes participate in the work to accept and sign the Informed Consent The patient will be screened in advance after the acceptance of it will be an anthropometric assessment, with assessment of height, weight and presence of associated comorbidities.

After clinical evaluation they headed for the initial evaluation, after this evaluation, patients are randomized and and delivered to the patient the medication with corticosteroids or placebo for an unrelated medical research. It is also given a bottle of paracetamol 750 mg and a sheet dated, in which the patient is instructed to register the day this sheet and number of capsules taken, which is also an evaluation factor.

evaluation VAS SF 36 Roland Morris questionnaire Test 6-minute walk Likert scale ELegibility Criteria

Clinical diagnosis:

Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.

Radiological diagnosis:

Presence of lumbar canal stenosis with an area less than 100mm2 Hamanishi based on criteria measured at lumbar spine MRI in the follow-up from L1 to S1.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.

Exclusion Criteria:

• decompensated diabetes mellitus.

• Systemic hypertension and decompensated heart

• systemic disease affecting the lower limbs

• Neuromuscular Disease

• Use of steroids in the past 3 months.

• Patients with previous surgery of the thoracic or lumbar spine.

• cognitive disorder that interferes with the ability to understand or interpret the questionnaires

• Spondylolisthesis except degenerative

• degenerative scoliosis with Cobb angle of 10 °

Study Design

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis of Lumbar Region

Intervention

Drug:
• predinose oral
1 mg for kg for 3 wekees
• placebo group
use a oral placebo

Locations

Country	Name	City	State
Brazil	Santa Mareclina Hospital	Sao Paulo
Brazil	Santa Marcelina Hospital	São Paulo	Sao paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of oral corticosteroids in the treatment of spinal stenosis	The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar stenosis.; use SF-36 VAS roland Moris questionnaire	3 months	Yes
Secondary	effectiveness and security of oral corticosteroids in the treatment of spinal stenosis	assess the safety of oral corticosteroids in patients with spinal stenosis and tolerability of patients with this medication control of sistemic diseases and safety with oral corticosteroids evaluation for osteoporotic patients in use of oral costicosteroids SF-36 VAS Roland Moris questionnaire 6 minuts walk test	3 months	Yes