跳至主要内容
临床试验/NCT03245073
NCT03245073已完成不适用

Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis

Acibadem University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

In this project, investigators aim to investigate the effects of action observation therapy on pain, fear of movement, functional level and brain hemodynamics in patients with knee osteoarthritis. The study is unique in that this method, which has already been used for post-surgical or motor healing, aims at long-term administration for the first time with chronic pain and objective visualization of the results. This study will create a new perspective to understand the physiology of pain, which has attracted much interest in the literature in recent years, and will shed light on the studies that can be done in this regard. Participants' joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions. In assessing pain, pain levels at rest and during activity will be questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The first group, will receive exercises with action observation therapy; and the second group will receive only exercises. The exercise programme will be administered under physiotherapist supervision for three days a week for six weeks. The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods.

详细描述

Osteoarthritis is a degenerative joint disease associated with pain and disability that occurs in 25% of the population over 18 years of age Worldwide. It is expected that osteoarthritis will be the fourth most common cause of disability in the World by 2020. Osteoarthritic joint has pathological changes such as damage of joint cartilage tissue, thickening of the subchondral bone, osteophyte formation, inflammation of synovium at different levels, degeneration of ligaments and meniscal structures and hypertrophy of joint capsule. In recent years, studies that relate chronic pain to neuroplasticity have demonstrated changes in the structure, function and somatotopic organization of the primary motor and sensory cortex of osteoarthritis patients with chronic pain. In addition to this, osteoarthritis studies showed that the pain does not originate solely from joint problems; the central nervous system is also responsible for the formation of pain sensation. Changes in the cortical sensorimotor areas include sensory disturbances, perceptual problems (differentiation of body image), and motor influences, and these changes are associated with severity and duration of pain. When the central nervous system targeted, pain may decrease better. Action observation therapy is a method which activates mirror neurons.

In this project, investigators aim to investigate the effects of action observation therapy on pain, fear of movement, functional level and brain hemodynamics in patients with knee osteoarthritis. The study is unique in that this method, which has already been used for post-surgical or motor healing, aims at long-term administration for the first time with chronic pain and objective visualization of the results. This study will create a new perspective to understand the physiology of pain, which has attracted much interest in the literature in recent years, and will shed light on the studies that can be done in this regard.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 45 to 70 years;
  • Unilateral knee osteoarthritis according to clinical and radiological criteria
  • Grade 2 or Grade 3 according to Kellgren-Lawrance Scale
  • Right-handed according to Edinburgh Handedness Scale
  • Chronic pain during the rest or activity above 4 points according to the Verbal Rating Scale

排除标准

  • Having neurological or psychiatric diseases
  • Having chronic pain due to another pain disorder
  • Having rheumatic diseases
  • Using antidepressant medications or opioids
  • Knee surgery within one year prior to the study
  • Intraarticular injection and attend physical therapy within 6 months prior to the study
  • Mini Mental State Examination Scale score below 24

结局指标

主要结局

Visual Analog Scale

时间窗: 6 weeks

Self reported pain intensity during rest and walking measured by 0-10 point scale.

Pressure pain threshold

时间窗: 6 weeks

Algometer (dolorimeter) will be used to assess the pressure pain threshold.

Brain Hemodynamics

时间窗: 6 weeks

Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özgül Öztürk

Doctor

Acibadem University

研究点 (1)

Loading locations...

相似试验