The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- effectiveness of oral corticosteroids in the treatment of spinal stenosis [ Time Frame: 3 months ]
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
- effectiveness and security of oral corticosteroids in the treatment of spinal stenosis [ Time Frame: 3 months ]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
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Active Comparator: corticosteroids, analgesics oral pill
Oral Corticosteroids and oral analgesics
Drug: predinose oral
1 mg for kg for 3 wekees
Placebo Comparator: placebo
oral placebo and oral analgesics
Drug: placebo group
use a oral placebo
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456377
|Santa Marcelina Hospital|
|São Paulo, Sao paulo, Brazil, 08270-070|
|Santa Mareclina Hospital|
|Sao Paulo, Brazil, 08270-070|