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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- effectiveness of oral corticosteroids in the treatment of spinal stenosis
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 °
研究组 & 干预措施
placebo
oral placebo and oral analgesics
干预措施: placebo group (Drug)
corticosteroids, analgesics oral pill
Oral Corticosteroids and oral analgesics
干预措施: predinose oral (Drug)
结局指标
主要结局
effectiveness of oral corticosteroids in the treatment of spinal stenosis
时间窗: 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
次要结局
- effectiveness and security of oral corticosteroids in the treatment of spinal stenosis(3 months)
研究者
Luiz Claudio Lacerda Rodrigues
assisten os spine surgeon group
Federal University of São Paulo