The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
- Conditions
- Spinal Stenosis of Lumbar Region
- Interventions
- Drug: placebo groupDrug: predinose oral
- Registration Number
- NCT01456377
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo group oral placebo and oral analgesics corticosteroids, analgesics oral pill predinose oral Oral Corticosteroids and oral analgesics
- Primary Outcome Measures
Name Time Method effectiveness of oral corticosteroids in the treatment of spinal stenosis 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
- Secondary Outcome Measures
Name Time Method effectiveness and security of oral corticosteroids in the treatment of spinal stenosis 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
Trial Locations
- Locations (2)
Santa Marcelina Hospital
🇧🇷São Paulo, Sao paulo, Brazil
Santa Mareclina Hospital
🇧🇷Sao Paulo, Brazil