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临床试验/NCT03984903
NCT03984903已完成不适用

Learning of Motor Control Exercises With Different Methods and Its Effects on Treatment Outcomes in Patients With Chronic Non-specific Low Back Pain: A Randomised Controlled Trial

Hacettepe University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2019年6月30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
30
试验地点
2
主要终点
Change from Baseline Pain Level at Eight Week and Third Month

研究概览

简要总结

This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

详细描述

For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.

So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

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
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic (>3 month), non-specific low back pain
  • 25- 55 years old
  • Have a capacity can understand exercise instructions (Montreal Cognitive Assessment > 21)
  • Being a computer literate

排除标准

  • Root nerve signs
  • Cauda equina syndrome
  • Fracture in the vertebra
  • Have a neurologic disease
  • History of spine surgery
  • Knowing motor control exercises
  • Visual impairment
  • Hearing loss

结局指标

主要结局

Change from Baseline Pain Level at Eight Week and Third Month

时间窗: At baseline, eighth week and third month

Full Scale Name: Visual Analog Scale Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.

Change from Baseline Disability Score Level at Eight Week and Third Month

时间窗: At baseline, eighth week and third month

Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0) The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.

Change in Exercise Adherence Level between Eight Week and Third Month

时间窗: At eighth week and third month

The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C. Section A, consists of 6 items not included in the scale scoring. Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high. Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.

次要结局

  • Change from Baseline Walking Parameters at Eight Week and Third Month(At baseline, eighth week and third month)

研究者

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

Utku BERBEROĞLU

Research Assistant

Hacettepe University

研究点 (2)

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