跳至主要内容
临床试验/NCT02435485
NCT02435485Unknown不适用

The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Biodex balance test

研究概览

简要总结

Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. There are very few research on the effectiveness of core spine stabilization exercise, balance training, and the balance effect while wearing lumbar corset in these patients.

Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance training and balance effect of the wearing of lumbar corset in patients with degenerative lumbar spondylolisthesis .

详细描述

Subjects :Seventy patients with lumbar spondylolisthesis will be randomly assigned to the group treated with balance training and without balance training, and another thirty-five age-matched lumbar spondylitis without spondylolisthesis will be assigned as control group.

Method: Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis will be recruited as experimental group and thirty-five patients with lumbar spondylitis will be recruited as control group. Exclusion criteria are patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment.

All subjects will receive Visual Analogue Scale (VAS), Oswestry Disability Index, Quebec back pain disability scale, and the postural stability test, 75% limits of stability test, modified clinical test of sensory integration, and the evaluation of fall risk test of Biodex balance system at beginning and at the end of program. Both the control and experimental groups will receive rehabilitation training, including hot packing, interferential therapy, core spine stabilization exercise and lower extremity strengthening exercise for 2-3 times a week, up to 8 weeks, 15 sessions in total. Patients in the experimental group will be randomly assigned to either a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program. The investigators will follow up with these patients by telephone 3 months after program completion.

The clinical history, age, gender, body weight, body height, job, symptoms and sign, Visual Analogue Scalce (VAS), Questionnairem (Quebec back pain disability scale) and Oswestry Disability Index will be recorded at base and after rehabilitation program. Every subject will sign the informed consent, which will be obtained from the Institutional Review Board of Chang Gung Memorial Hospital.

Physical examination It will include the duration, pain intensity, neurologic deficits, muscle power of lower limbs, deep tendon reflex, sensation, stretch sign or nerve conduction velocity, or electromyography examination.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, low back pain, or radicular symptoms and diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis as the experimental group and thirty-five patients with lumbar spondylitis will be included as the control group.

排除标准

  • Patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment. -

研究组 & 干预措施

spondylolisthesis with balance training

Experimental

Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise.

干预措施: Biodex balance training (Device)

spondylolisthesis with balance training

Experimental

Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise.

干预措施: Rehabilitation including core spinal stabilization exercise (Other)

spondylolisthesis, no balance training

Active Comparator

Intervention: Regular rehabilitation including core spinal stabilization exercise

干预措施: Rehabilitation including core spinal stabilization exercise (Other)

lumbar spondylitis

Active Comparator

Intervention: Regular rehabilitation including core spinal stabilization exercise

干预措施: Rehabilitation including core spinal stabilization exercise (Other)

结局指标

主要结局

Biodex balance test

时间窗: 8 weeks, 6 months

1. Postural stability test: overall index___, anterior-posterior index___, medial-lateral index____ 2. Limits of stability test: forward___, backward___, right___, left___, forward/right___, forward/left___, backward/right___, backward/left___ 3. Modified clinical test of sensory integration: sway index: eye open, firm___; eye close,firm___, eye open, foam___, eye close foam___ 4. Fall risk test: actual score, STD_______

次要结局

  • Visual analog scale (VAS) of low back pain and radicular pain(8 weeks, 6 months)
  • Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire)(8 week, 6 months)
  • Quebec back pain disability scale(8 weeks, 6 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Yun Liaw

Department of physical medicine and rehabilitation

Chang Gung Memorial Hospital

研究点 (2)

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