Prospective Study Comparing Surgical Decompression Associated With Physical Therapy And Physical Therapy Isolated In Patients With Lumbar Canal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in Pain
研究概览
简要总结
Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow ligament, the articular capsule and the intervertebral disk. These changes decrease the area of the spinal canal and press the neural structures and may present clinically as the narrow tunnel syndrome.
This presentation was first described by Verbiest associated with these anatomical changes the clinical manifestations; corresponding to low back pain, pain in the legs that worsen with the fact ambulate and improve with rest, this presentation called neurogenic claudication .
The lumbar canal stenosis was divided into two main types; congenital and acquired . The first is associated with a reduced size of the pedicles, which leads to a reduction of the diameter of the spinal canal, common in patients achondroplasics . The acquired is considered the most common type and is associated with aging, including all anatomical structures of the lumbar segment .
With an aging population the number of symptomatic patients is increasing, although there is no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical approaches to the spine in patients over 60 years of age (7).
As described by Daffner et al a reduction in blood flow leads to production of inflammatory mediators, which associated with anatomical changes previously described lead to the clinical picture with lameness and pain in the lower limbs Treatment of these patients is beginning with guidance on the disease, adequate pain control, physical therapy and exercise for maintaining the activities of daily living. If these measures fail a surgical approach may be necessary, especially in patients with exercise intolerance, difficulty walking and urinary incontinence .
The surgical approach despite being widely studied in the literature prospective controlled studies are rare, found series of case studies or retrospective studies, we try to evaluate the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt to assess the impact of surgery associated with comparing therapy with isolated therapy in these patients.
详细描述
Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow ligament, the articular capsule and the intervertebral disk. These changes decrease the area of the spinal canal and press the neural structures and may present clinically as the narrow tunnel syndrome.
This presentation was first described by Verbiest associated with these anatomical changes the clinical manifestations; corresponding to low back pain, pain in the legs that worsen with the fact ambulate and improve with rest, this presentation called neurogenic claudication .
The lumbar canal stenosis was divided into two main types; congenital and acquired . The first is associated with a reduced size of the pedicles, which leads to a reduction of the diameter of the spinal canal, common in patients achondroplasics . The acquired is considered the most common type and is associated with aging, including all anatomical structures of the lumbar segment .
With an aging population the number of symptomatic patients is increasing, although there is no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical approaches to the spine in patients over 60 years of age .
As described by Daffner et al a reduction in blood flow leads to production of inflammatory mediators, which associated with anatomical changes previously described lead to the clinical picture with lameness and pain in the lower limbs Treatment of these patients is beginning with guidance on the disease, adequate pain control, physical therapy and exercise for maintaining the activities of daily living. If these measures fail a surgical approach may be necessary, especially in patients with exercise intolerance, difficulty walking and urinary incontinence .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, 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
- •claudication Presence less than 100m ambulation;
- •Pain in the lower limbs;
- •Weakness in lower limbs;
- •Burning in the lower limbs;
- •Tingling in the lower limbs;
- •Low back pain;
- •the lower spinal canal area to 100mm2, at the discretion of Hamanishi.
排除标准
- •decompensated diabetes mellitus;
- •Systemic hypertension and decompensated heart disease;
- •Systemic diseases to occur in the lower limbs;
- •Neuromuscular diseases;
- •Patients with previous surgery in the lumbar or thoracic spine;
- •Cognitive impairment that interferes with the ability to understand or interpret the questionnaires;
结局指标
主要结局
Change in Pain
时间窗: Baseline, after 4, 12, 24 and 48 weeks
Measured using the VAS
次要结局
- Change in walking distance(Baseline, after 4, 12, 24 and 48 weeks)
- Change in quality of life(Baseline, after 4, 12, 24 and 48 weeks)
- Change in function(Baseline, after 4, 12, 24 and 48 weeks)
研究者
Luiz Claudio Lacerda Rodrigues
Chief Of Orthopedics And Traumatology Discipline Medical School Santa Marcelina
Federal University of São Paulo