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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245073
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Özgül Öztürk, Acibadem University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Osteoarthritis, Knee Other: Action observation therapy Other: Exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise
Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
Other: Exercise
Strengthening and stretching exercise programme focuses on hip and knee muscles

Experimental: Action observation therapy and exercise
Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles
Other: Action observation therapy
The normal human movement will be recorded and than the patients will be watched them.

Other: Exercise
Strengthening and stretching exercise programme focuses on hip and knee muscles




Primary Outcome Measures :
  1. Brain Hemodynamics [ Time Frame: 6 weeks ]
    Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.

  2. Pressure pain threshold [ Time Frame: 6 weeks ]
    Algometer (dolorimeter) will be used to assess the pressure pain threshold.

  3. Visual Analog Scale [ Time Frame: 6 weeks ]
    Self reported pain intensity during rest and walking measured by 0-10 point scale.


Other Outcome Measures:
  1. Western Ontario and Mcmaster Universities Osteoarthritis Index [ Time Frame: 6 weeks ]
    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

  2. Kinesiophobia [ Time Frame: 6 weeks ]
    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.

  3. Pain Catastrophization [ Time Frame: 6 weeks ]
    Pain Catastorphization Scale is a self-reported scale, and will be assessed to detect the level of pain catastrophization



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245073


Locations
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Turkey
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Acibadem University
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Responsible Party: Özgül Öztürk, Doctor, Acibadem University
ClinicalTrials.gov Identifier: NCT03245073    
Other Study ID Numbers: ATADEK-2017/8
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations