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临床试验/NCT01985776
NCT01985776已完成不适用

Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis

University of Primorska4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
4
主要终点
Changes in measures of neuromuscular functions of the trunk

研究概览

简要总结

The first purpose of this study is to define parameters of the trunk neuromuscular functions that are pathologically altered in patients with low back pain due to spondylolytic spondylolisthesis. The second and also the main purpose of the study is to examine the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve neuromuscular functions of the trunk in patients with low back pain due to spondylolytic spondylolisthesis.

详细描述

Low back pain is known to affect a considerable portion (> 75%) of the society, causing enormous financial burden for the healthcare systems.

Exercise interventions incorporated into low back pain patients rehabilitation protocols are known as successful treatment strategies, but ore often focused on strength training and not on functional stabilization. Spondylolytic spondylolisthesis is one of the most known types of spine instabilities. To date, no studies examined the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. Research will be carried out as a cross-sectional study, where patients with spondylolytic spondylolisthesis will be randomly arranged in one controlled and two experimental groups. For the forth group healthy asymptomatic participants will be recruited.

Exercise intervention will last 12 weeks with a frequency of three times a week and duration of 60 minutes per training unit. Exercise intervention will include congregated set of trunk stabilisation exercises, starting with simple isometric tasks. Dynamic and more complex movements will be added progressively to achieve whole body tasks involving fast and sudden movements.

Neuromuscular functions of the trunk will be measured before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Low back pain presence for at least three months.
  • Age between 20 and 60 years.
  • Isthmic Spondylolisthesis (1st and 2nd level according to Meyerding) at L5/S1 and L4/L
  • Body mass index below
  • without neurological pathological conditions.

排除标准

  • Intermittent claudication pain.
  • History of operational treatment of the lumbar spine.
  • Traumatic, oncological, infectional pathology of the spine
  • Degenerative stenosis of the lumbar spinal canal.

研究组 & 干预措施

Exercise intervention

Active Comparator

Patients will functional stabilisation exercise for the trunk.

干预措施: Exercise intervention (Procedure)

Exercise and e-stim

Active Comparator

Patients will receive exercise intervention and electrical stimulation simultaneously.

干预措施: Exercise and e-stim (Procedure)

Patients control

No Intervention

Patients will not receive any treatment but could use compression belt as per usual.

Healthy control

No Intervention

Healthy asymptomatic participants who will not receive any treatment.

结局指标

主要结局

Changes in measures of neuromuscular functions of the trunk

时间窗: Change from baseline values at 9 weeks

Set of tests that objectively evaluate the neuromuscular functions of the trunk. * Ability to reposition the trunk position during forward bent * Maximal voluntary contraction during trunk flexion, extension and lateral flexion * Muscle endurance during isometric trunk extension. * Trunk's muscles activation during sudden loading and fast arm movement * Single leg stance * Leg symmetry during squat * Hip and spine flexibility

次要结局

  • Changes in Oswestry questionnaire score(Change from baseline values at 9 weeks)
  • Change in Posture parameters(Change from baseline values at 9 weeks)

研究者

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

Nejc Sarabon

Assoc. Prof. Dr. Sc.

University of Primorska

研究点 (4)

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