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临床试验/NCT04099576
NCT04099576已完成不适用

Physiotherapy Combined With Therapeutic Neuroscience Education Versus Physiotherapy Alone for Patients With Chronic Low Back Pain: a Randomized Controlled Trial

Pamukkale University2 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2016年11月7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
31
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

Ongoing fear and catastrophization in people with chronic low back pain (CLBP) causes increased pain, disability and kinesiophobia, and decreased endurance of trunk muscles. Nowadays, recurrent low back pain complaints are increasing day by day. Besides the use of electrophysical agents and exercise in the treatment of chronic low back pain, education methods used to reduce the negative effects of psychosocial factors are important for healing.

Although there were studies about the combination of Therapeutic Neuroscience Education (TNE) with exercise in CLBP, there are no studies that combine electrophysical agents, exercise and TNE methods in the literature. Therefore, in this study, we aimed to investigate whether TNE combined with physiotherapy consisting of electrophysical modalities and home program exercise is superior to only physiotherapy in patients with CLBP.

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
Single (Participant)

入排标准

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

入选标准

  • The inclusion criteria were:
  • aged between 18-60 years
  • to have CLBP ˃ 3 months duration
  • to have independent walking ability
  • to be literate in Turkish.

排除标准

  • to have vertebral compression fractures
  • to have transitional vertebrae
  • to have an underlying tumoral, rheumatologic or inflammatory disease
  • to have trauma, surgical history
  • to be pregnant or less than six months postpartum period

结局指标

主要结局

Visual Analogue Scale

时间窗: 1 minute

Visual Analogue Scale assessed pain severity. Visual Analog Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of pain. hence the left end is usually labeled 'no pain', and the right end usually labeled 'extreme pain'. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark by using a ruler. The scale is provided a range of scores from 0-100. High score indicates a high level of pain.

Tampa Kinesiophobia Scale

时间窗: Five minutes

Tampa Kinesiophobia Scale (TKS) evaluated kinesiophobia. TKS is a questionnaire evaluating kinesiophobia due to low back pain. The TKS questionnaire contained 17 items that assessed fear-related concepts. Each item has a four-point Likert scale with scoring options tiered from "strongly agree" to "strongly disagree" and a total score ranging from 17 to 68. Higher scores represented stronger levels of fear avoidance behavior.

次要结局

  • partial curl-up(1 minute)
  • Roland Morris Index(Five minutes)
  • modified Sorensen tests(Five minutes)

研究者

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

Suat EREL

Professor

Pamukkale University

研究点 (2)

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