Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
2020年1月20日 更新者：Shin Kong Wu Ho-Su Memorial Hospital
To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.
研究概览
详细说明
Low back pain (LBP) is a very common health problem which results in negative impact in daily life and burden especially in elderly. The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%. Among the etiologies of low back pain, lumbar spinal stenosis is frequently encountered by physicians. In a large observational study, the prevalence of lumbar spinal stenosis was 23.6% in the general population and higher in patients more than 60 years-old. If untreated, the symptoms may persist in 70% of the patients over the 48-month observation period. On the other hand, previous studies have shown that surgery is more effective in pain relief, neurological symptoms and further functional status, however, conservative treatment still had favorable effect in patients with milder symptoms.
The role of spinal manipulation has been discussed in previous study which compared the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disc herniation. According to this study, the pain, disability and life quality of both groups in 12-week period had no significant difference that chiropractic spinal manipulative treatment could be considered as a primary treatment. However, comparison among the effect of spinal manipulation, physical therapy, and surgery has not been conducted before. Therefore, the purpose of this study is to compare the effect of spinal manipulation, physical therapy, and surgery in the treatment of lumbar spinal stenosis.
研究类型
介入性
注册 (实际的)
14
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Taipei、台湾
- ShinKongHospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 20 to 80 age years old
- Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS>=4)
- Symptom duration is more than three months
- The diagnosis is proved by MRI
Exclusion Criteria:
- Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
- Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
- Concomitant serious medical conditions
- History of spinal surgery before
- Severe osteoporosis or instability of the lumbar spine
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Lumbar spinal manipulation
Lumbar spinal manipulation will be performed up to 8 times within 1 month (no more than 2 times per week) by Dr. WangTso-Liang, who is a well-trained and experienced manual therapy doctor.
If the symptoms subside before the end of 1 month' treatment, the manipulation is discontinued.
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有源比较器：Physical therapy
Physical therapy will include treatment with therapeutic exercise and modalities (lumbar traction, heattherapy, electric stimulation, and therapeutic exercise) for 2 month with frequency 3 times per week.
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有源比较器：Surgery
General anesthesia, the patient will be put in the prone and abdomen-free position.
A 4-cm midline longitudinal incision will be made over the spinous processes of the L3-5 levels.
It will be deepened through the fat and fascia in line with the skin incision to reach the spinous processes.The paraspinous muscles will be dissected subperiosteally down the spinous processes and along the lamina to the facet joints.
Laminectomy will be done carefully at the herniated disc level for posterior decompression.
The ligamentum flavum will be excised to expose the dural sac.Using blunt dissection, the investigators carefully continue down the lateral side of the dura to the floor of the spinal canal; the investigators retract the dura and its nerve root medially.
After the posterior aspect of the disc space is revealed, the affected disc will be removed and discotomy will be performed.The wound will be closed in the routine fashion after meticulous hemostasis and normal saline irrigation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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VAS pain score
大体时间：Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Modified OswestryDisability Questionnaire (MODQ)
大体时间：Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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For evaluation of disability related to LBP, Oswestry Disability Questionnaire (ODQ) is most widely used.
ODQ is a 10-item self report instrument that evaluates perceived disability in 10 areas: pain intensity, ability to lift objects, ability to walk, ability to sit, ability to stand, ability to sleep, sex life, social life, traveling, and ability to complete personal hygiene activities.
By using a 6-point Likert scale (0 = no limitation; 5 = severe limitation) , the total maximum scale is doubled and reported as a percentage of the patients perceived pain-related disability, with higher scores indicating greater disability.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Swiss Spinal Stenosis Questionnaire
大体时间：Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Swiss Spinal Stenosis Questionnaire is a disease-specific self-report outcome instrument commonly used in patients with lumbar spinal stenosis (LSS) for evaluation of outcomes of the treatment.
It includes severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with LSS.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Medical Outcome Survey Short Form (SF-36)
大体时间：Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Medical Outcome Survey Short Form (SF-36) was used to assess general health status.
The SF-36 measures eight dimentions of health: general health perceptions, physical function, physical role, bodily pain, social functioning, mental health, emotional role, and vitality.
The eight scales may be combined into two summary scores, the physical component summary(PCS) and the mental component summary(MCS).
The SF-36 has well-established psychometric properties for the general population and individuals with LBP.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Intermittent claudication
大体时间：Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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For evaluation of intermittent claudication, self-reported duration of walking will be recorded.
It divides into three levels to evaluate how long the patient can walk without resting.
The duration includes less than 10 minutes, 11-20 minutes, 21-30 minutes and more than 30 minutes.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Lin-Fen Hsieh, M.D、Shin Kong Wu Ho-Su Memorial Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2019年12月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2017年4月7日
首先提交符合 QC 标准的
2017年4月12日
首次发布 (实际的)
2017年4月18日
研究记录更新
最后更新发布 (实际的)
2020年1月22日
上次提交的符合 QC 标准的更新
2020年1月20日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
腰椎牵引的临床试验
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University of AlbertaCurtin University; American Orthotic and Prosthetic Association招聘中