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
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
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| Completed |
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N/A | |
| Completed |
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Phase 4 |