The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
NCT ID: NCT01456377
Last Updated: 2011-10-20
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2011-07-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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corticosteroids, analgesics oral pill
Oral Corticosteroids and oral analgesics
predinose oral
1 mg for kg for 3 wekees
placebo
oral placebo and oral analgesics
placebo group
use a oral placebo
Interventions
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predinose oral
1 mg for kg for 3 wekees
placebo group
use a oral placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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 °
50 Years
75 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Luiz Claudio Lacerda Rodrigues
assisten os spine surgeon group
Locations
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Santa Marcelina Hospital
São Paulo, São Paulo, Brazil
Santa Mareclina Hospital
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1892/10
Identifier Type: -
Identifier Source: org_study_id