<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/NCT03792165</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK 2017/8</org_study_id>
    <nct_id>NCT03792165</nct_id>
  </id_info>
  <brief_title>Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis</brief_title>
  <official_title>Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haydarpasa Numune Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The investigators aim to explore the effects of action observation therapy on pain and brain&#xD;
      hemodynamics in patients with knee osteoarthritis. This study will create a new perspective&#xD;
      to understand the physiology of pain, by applying painful stimulation during the neuroimaging&#xD;
      system which has attracted much interest in the literature in recent years, and will shed&#xD;
      light on the studies that can be done in this regard. Participants' pain level will be&#xD;
      assessed using Visual Analog Scale and pressure algometer. Also joint range of motion in the&#xD;
      initial assessments will be measured by electro-goniometer, muscle strength assessment by&#xD;
      JTech hand dynamometer at appropriate evaluation positions. Fear of movement of individuals&#xD;
      will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via&#xD;
      Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and&#xD;
      Go Test. Functional near infrared spectroscopy (fNIRS) will be used for evaluation of brain&#xD;
      hemodynamics. The first group, will receive exercises with action observation therapy; and&#xD;
      the second group will receive only exercises. The exercise programme will be administered&#xD;
      under physiotherapist supervision for three days a week for six weeks. The evaluations will&#xD;
      be repeated at the beginning of the study and at the end of the sixth week. Data obtained&#xD;
      from the study will be analyzed using appropriate statistical methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      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. Pain is the most common symptom in osteoarthritic patients and the ongoing pain&#xD;
      effects quality of life and physical functions of them negatively. At the same time, decrease&#xD;
      in joint range of motion, muscle strength loss and decline in functional level may go along&#xD;
      with pain. 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. It is reported that approaches targeting cortical&#xD;
      reorganization resulted in decreased pain and increased function. Action observation therapy&#xD;
      is a method which activates mirror neurons and is applied to learn a specific motor skill,&#xD;
      facilitate motor learning and decrease the pain level of the extremities. It is anticipated&#xD;
      that action observation therapy may differentiate perception of pain by altering cortical&#xD;
      activity and thus altered motor cortical activity may play an active role in reducing pain by&#xD;
      modulating pain-related neural networks.&#xD;
&#xD;
      The investigators aim to explore the effects of action observation therapy on pain and brain&#xD;
      hemodynamics in patients with knee osteoarthritis. This study will create a new perspective&#xD;
      to understand the physiology of pain, by applying painful stimulation during the neuroimaging&#xD;
      system which has attracted much interest in the literature in recent years, and will shed&#xD;
      light on the studies that can be done in this regard. Participants' pain level will be&#xD;
      assessed using Visual Analog Scale and pressure algometer. Also joint range of motion in the&#xD;
      initial assessments will be measured by electro-goniometer, muscle strength assessment by&#xD;
      JTech hand dynamometer at appropriate evaluation positions.Fear of movement of individuals&#xD;
      will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via&#xD;
      Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and&#xD;
      Go Test. Functional near infrared spectroscopy (fNIRS) will be used for evaluation of brain&#xD;
      hemodynamics. The first group, will receive exercises with action observation therapy; and&#xD;
      the second group will receive only exercises. The exercise programme will be administered&#xD;
      under physiotherapist supervision for three days a week for six weeks. The evaluations will&#xD;
      be repeated at the beginning of the study and at the end of the sixth week. Data obtained&#xD;
      from the study will be analyzed using appropriate statistical methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 8, 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>Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)</measure>
    <time_frame>6 weeks</time_frame>
    <description>In order to assess the brain hemodynamics during the painful and non painful stimulations of patients functional near infrared spectroscopy (NIRX Medical Technologies NIRScout) will be used. This neuroimaging method will be applied with 16 detector and 16 source which implanted via a cap. Firstly, the patients' pain pressure threshold level at knee region will be determined, then this value will be considered as painful stimulation. For non-painful stimulation 5 N will be applied to the patient. Hemodynamic responses will be evaluated according to the cortical areas (prefrontal cortex, premotor and supplementary motor cortex, primer motor cortex, primer somatosensory cortex)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Level</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self reported pain intensity during the rest and the activity measured by Visual Analog Scale which presented as a 10 centimeter horizontal line and 0 means no pain, 10 means unbearable pain.</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, whereby the medial middle point of the knee and 2 cm lateral to the medial malleol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tampa Kinesiophobia 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. The total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and Mcmaster Universities Osteoarthritis Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>WOMAC is 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. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>6 weeks</time_frame>
    <description>Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>6 weeks</time_frame>
    <description>Knee range of motion will be evaluated by digital goniometer. Knee flexion, knee extension, ankle dorsi and plantar flexion will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Action Observation Therapy</condition>
  <condition>Functional Near Infared Spectroscopy</condition>
  <condition>Exercise</condition>
  <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>
  <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>
  <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;
          -  MMSE&gt;21&#xD;
&#xD;
          -  Chronic knee pain (VAS score&gt;5)&#xD;
&#xD;
          -  Right dominant&#xD;
&#xD;
          -  Unilateral knee pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain characteristics such as the presence of a rheumatologic disease other than knee&#xD;
             osteoarthritis, lumbar radiculopathy, systemic inflammatory disease, diabetic&#xD;
             neuropathy, problems similar to knee osteoarthritis,&#xD;
&#xD;
          -  Hearing or vision problems,&#xD;
&#xD;
          -  Injection therapy involving the knee region within the last 6 months,&#xD;
&#xD;
          -  Surgical operation involving the knee region&#xD;
&#xD;
          -  Psychiatric problems and anti-depressant usage&#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>Özgül Öztürk</name>
      <address>
        <city>İstanbul</city>
        <zip>34752</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</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>Lecturer</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>
  </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/NCT03792165
org study id: ATADEK 2017/8
nct id: NCT03792165
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The investigators aim to explore the effects of action observation therapy on pain and brain
      hemodynamics in patients with knee osteoarthritis. This study will create a new perspective
      to understand the physiology of pain, by applying painful stimulation during the neuroimaging
      system 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' pain level will be
      assessed using Visual Analog Scale and pressure algometer. Also 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. 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.
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. Pain is the most common symptom in osteoarthritic patients and the ongoing pain
      effects quality of life and physical functions of them negatively. At the same time, decrease
      in joint range of motion, muscle strength loss and decline in functional level may go along
      with pain. 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. It is reported that approaches targeting cortical
      reorganization resulted in decreased pain and increased function. Action observation therapy
      is a method which activates mirror neurons and is applied to learn a specific motor skill,
      facilitate motor learning and decrease the pain level of the extremities. It is anticipated
      that action observation therapy may differentiate perception of pain by altering cortical
      activity and thus altered motor cortical activity may play an active role in reducing pain by
      modulating pain-related neural networks.

      The investigators aim to explore the effects of action observation therapy on pain and brain
      hemodynamics in patients with knee osteoarthritis. This study will create a new perspective
      to understand the physiology of pain, by applying painful stimulation during the neuroimaging
      system 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' pain level will be
      assessed using Visual Analog Scale and pressure algometer. Also 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.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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)
time frame: 6 weeks
description: In order to assess the brain hemodynamics during the painful and non painful stimulations of patients functional near infrared spectroscopy (NIRX Medical Technologies NIRScout) will be used. This neuroimaging method will be applied with 16 detector and 16 source which implanted via a cap. Firstly, the patients' pain pressure threshold level at knee region will be determined, then this value will be considered as painful stimulation. For non-painful stimulation 5 N will be applied to the patient. Hemodynamic responses will be evaluated according to the cortical areas (prefrontal cortex, premotor and supplementary motor cortex, primer motor cortex, primer somatosensory cortex)
measure: Pain Level
time frame: 6 weeks
description: Self reported pain intensity during the rest and the activity measured by Visual Analog Scale which presented as a 10 centimeter horizontal line and 0 means no pain, 10 means unbearable pain.
measure: Pressure pain threshold
time frame: 6 weeks
description: Algometer (dolorimeter) will be used to assess the pressure pain threshold, whereby the medial middle point of the knee and 2 cm lateral to the medial malleol.
measure: Kinesiophobia
time frame: 6 weeks
description: Tampa Kinesiophobia 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. The total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia.
measure: Western Ontario and Mcmaster Universities Osteoarthritis Index
time frame: 6 weeks
description: WOMAC is 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. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.
measure: Muscle strength
time frame: 6 weeks
description: Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.
measure: Range of motion
time frame: 6 weeks
description: Knee range of motion will be evaluated by digital goniometer. Knee flexion, knee extension, ankle dorsi and plantar flexion will be assessed.
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
arm group label: Exercise
arm group type: Active Comparator
description: Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
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: Lecturer
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No