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临床试验/NCT04330885
NCT04330885已完成不适用

PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change of Disability level

研究概览

简要总结

Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60. LSS is the most common reason to perform spinal surgery for people aged >65 years and have been shown to be superior to conservative treatment. Hitherto, studies on lumbar spinal stenosis are sparse with only 3 trials including approximately 300 patients. There is also a paucity in studies investigating if people with lumbar spinal stenosis improve their outcome following surgery undergoing a pre-surgery rehabilitation programme including physical fitness exercises, abdominal and back muscle strengthening and a core control approach.

详细描述

Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60. This age group with neurogenic claudication is expected to rise dramatically over the next 20 years when an estimated 23-25 % of the population will be > 60 years. Lumbar spinal stenosis is the most common reason to perform spinal surgery for people aged >65 years and have been shown to be superior to conservative treatment. Conservative treatment post-operatively have recently been described in a Cochrane review to be of importance. Hitherto, studies on lumbar spinal stenosisare sparse with only 3 trials including approximately 300 patients. There is also a paucity in studies investigating if people with lumbar spinal stenosis improve their outcome following surgery undergoing a pre-surgery rehabilitation programme including physical fitness exercises, abdominal and back muscle strengthening and a core control approach.

Aim: The aim of the current study was to evaluate a pre-surgery rehabilitation intervention for patients diagnosed with lumbar spinal stenosis found eligible for a decompression surgery. A further aim was to conduct a qualitative study to explore the experience of symptoms in relation to all-day-living and quality of life among those who have undergone a decompression surgery for lumbar spinal stenosis.

Methods: Patients consecutively seeking or referred for orthopaedic surgery at Spine Clinic in Stockholm will, if found eligible and given their informed consent be randomized into two separate groups following a consultant visit to an orthopaedic surgeon; 1) A pre-habilitation program of 8 weeks before decompression surgery 2) Care as usual, that is information from physiotherapists 2 weeks before surgery and the advice to stay active. Those eligible for decompression surgery are patients aged 50-75 with pseudo-claudication in one or both legs and back pain (VAS>30), magnetic resonance camera with 1-2 adjacent stenotic segments (L3-S1) (area ≤75mm2), duration of symptoms >6 months.

Both written and oral information of the study will be given and the patients will give their written consent. An independent physiotherapist blinded to patient assignment will sequentially number the envelopes containing intervention assignments according to a computer-generated randomization. Opaque and sealed envelopes will be opened in front of the participants at the end of the initial assessment visit. The main applicant will be responsible for data collection, to set up the program and educate included physiotherapists, to be responsible for analyses of data and for ethical application.

For the secondary aim a strategic sample of patients from both groups following the surgery will be included to conduct semi-structured deep interviews to explore their experience of facilitators and barriers to every day life both before and after the surgery. The interviews will take place 3 months following the surgery. The collected data will be analysed according a content analysis with categories, sub categories and themes.

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 (Investigator, Outcomes Assessor)

盲法说明

Investigator does not take part in data collection. All data collected via web based surveys.

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

入选标准

  • Spinal stenosis
  • Eligible for decompression surgery
  • aged 50-75 years
  • pseudo-claudication in one or both legs
  • back pain (VAS>30),
  • MRI with 1-2 adjacent stenotic segments (L3-S1) (area ≤75mm2),
  • duration of symptoms >6 months.

排除标准

  • 未提供

结局指标

主要结局

Change of Disability level

时间窗: 6 weeks pre-surgery, pre surgery, 3 and 12 months after surgery

Oswestry Disability Index 0-100, higher value means more functional limitations

Change of Pain level: Numeric pain rating scale 0-11

时间窗: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

Numeric pain rating scale 0-10, higher value means more pain

次要结局

  • Change of Fear of movement(6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery)
  • Change of Self efficacy: Self efficacy scale 0-64(6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery)
  • Change of General Health higher value means better health(6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better health)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Rasmussen Barr

Associated professor

Karolinska Institutet

研究点 (1)

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