<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03245073</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK-2017/8</org_study_id>
    <nct_id>NCT03245073</nct_id>
  </id_info>
  <brief_title>Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis</brief_title>
  <official_title>Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this project, investigators aim to investigate the effects of action observation therapy&#xD;
      on pain, fear of movement, functional level and brain hemodynamics in patients with knee&#xD;
      osteoarthritis. The study is unique in that this method, which has already been used for&#xD;
      post-surgical or motor healing, aims at long-term administration for the first time with&#xD;
      chronic pain and objective visualization of the results. This study will create a new&#xD;
      perspective to understand the physiology of pain, which has attracted much interest in the&#xD;
      literature in recent years, and will shed light on the studies that can be done in this&#xD;
      regard. Participants' joint range of motion in the initial assessments will be measured by&#xD;
      electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate&#xD;
      evaluation positions. In assessing pain, pain levels at rest and during activity will be&#xD;
      questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via&#xD;
      Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and&#xD;
      McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional&#xD;
      near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The&#xD;
      first group, will receive exercises with action observation therapy; and the second group&#xD;
      will receive only exercises. The exercise programme will be administered under&#xD;
      physiotherapist supervision for three days a week for six weeks. The evaluations will be&#xD;
      repeated at the beginning of the study and at the end of the sixth week. Data obtained from&#xD;
      the study will be analyzed using appropriate statistical methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis is a degenerative joint disease associated with pain and disability that&#xD;
      occurs in 25% of the population over 18 years of age Worldwide. It is expected that&#xD;
      osteoarthritis will be the fourth most common cause of disability in the World by 2020.&#xD;
      Osteoarthritic joint has pathological changes such as damage of joint cartilage tissue,&#xD;
      thickening of the subchondral bone, osteophyte formation, inflammation of synovium at&#xD;
      different levels, degeneration of ligaments and meniscal structures and hypertrophy of joint&#xD;
      capsule. In recent years, studies that relate chronic pain to neuroplasticity have&#xD;
      demonstrated changes in the structure, function and somatotopic organization of the primary&#xD;
      motor and sensory cortex of osteoarthritis patients with chronic pain. In addition to this,&#xD;
      osteoarthritis studies showed that the pain does not originate solely from joint problems;&#xD;
      the central nervous system is also responsible for the formation of pain sensation. Changes&#xD;
      in the cortical sensorimotor areas include sensory disturbances, perceptual problems&#xD;
      (differentiation of body image), and motor influences, and these changes are associated with&#xD;
      severity and duration of pain. When the central nervous system targeted, pain may decrease&#xD;
      better. Action observation therapy is a method which activates mirror neurons.&#xD;
&#xD;
      In this project, investigators aim to investigate the effects of action observation therapy&#xD;
      on pain, fear of movement, functional level and brain hemodynamics in patients with knee&#xD;
      osteoarthritis. The study is unique in that this method, which has already been used for&#xD;
      post-surgical or motor healing, aims at long-term administration for the first time with&#xD;
      chronic pain and objective visualization of the results. This study will create a new&#xD;
      perspective to understand the physiology of pain, which has attracted much interest in the&#xD;
      literature in recent years, and will shed light on the studies that can be done in this&#xD;
      regard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">May 18, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain Hemodynamics</measure>
    <time_frame>6 weeks</time_frame>
    <description>Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>6 weeks</time_frame>
    <description>Algometer (dolorimeter) will be used to assess the pressure pain threshold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self reported pain intensity during rest and walking measured by 0-10 point scale.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Western Ontario and Mcmaster Universities Osteoarthritis Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>WOMAC is a self-reported scale used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties</description>
  </other_outcome>
  <other_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tampa Kinesiophobia Scale is a self-reported scale, will be used to assess the fear of movement. It is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Catastrophization</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pain Catastorphization Scale is a self-reported scale, and will be assessed to detect the level of pain catastrophization</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Action observation therapy and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Action observation therapy</intervention_name>
    <description>The normal human movement will be recorded and than the patients will be watched them.</description>
    <arm_group_label>Action observation therapy and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Strengthening and stretching exercise programme focuses on hip and knee muscles</description>
    <arm_group_label>Action observation therapy and exercise</arm_group_label>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 45 to 70 years;&#xD;
&#xD;
          -  Unilateral knee osteoarthritis according to clinical and radiological criteria&#xD;
&#xD;
          -  Grade 2 or Grade 3 according to Kellgren-Lawrance Scale&#xD;
&#xD;
          -  Right-handed according to Edinburgh Handedness Scale&#xD;
&#xD;
          -  Chronic pain during the rest or activity above 4 points according to the Verbal Rating&#xD;
             Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having neurological or psychiatric diseases&#xD;
&#xD;
          -  Having chronic pain due to another pain disorder&#xD;
&#xD;
          -  Having rheumatic diseases&#xD;
&#xD;
          -  Using antidepressant medications or opioids&#xD;
&#xD;
          -  Knee surgery within one year prior to the study&#xD;
&#xD;
          -  Intraarticular injection and attend physical therapy within 6 months prior to the&#xD;
             study&#xD;
&#xD;
          -  Mini Mental State Examination Scale score below 24&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haydarpasa Numune Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Özgül Öztürk</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245073
org study id: ATADEK-2017/8
nct id: NCT03245073
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Brain Hemodynamics
time frame: 6 weeks
description: Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.
measure: Pressure pain threshold
time frame: 6 weeks
description: Algometer (dolorimeter) will be used to assess the pressure pain threshold.
measure: Visual Analog Scale
time frame: 6 weeks
description: Self reported pain intensity during rest and walking measured by 0-10 point scale.
measure: Western Ontario and Mcmaster Universities Osteoarthritis Index
time frame: 6 weeks
description: WOMAC is a self-reported scale used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties
measure: Kinesiophobia
time frame: 6 weeks
description: Tampa Kinesiophobia Scale is a self-reported scale, will be used to assess the fear of movement. It is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
measure: Pain Catastrophization
time frame: 6 weeks
description: Pain Catastorphization Scale is a self-reported scale, and will be assessed to detect the level of pain catastrophization
arm group label: Exercise
arm group type: Active Comparator
description: Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
arm group label: Action observation therapy and exercise
arm group type: Experimental
description: Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles
intervention type: Other
intervention name: Action observation therapy
description: The normal human movement will be recorded and than the patients will be watched them.
arm group label: Action observation therapy and exercise
intervention type: Other
intervention name: Exercise
description: Strengthening and stretching exercise programme focuses on hip and knee muscles
arm group label: Action observation therapy and exercise
arm group label: Exercise
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Özgül Öztürk
investigator title: Doctor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Chronic Pain
sharing ipd: No