Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
Primary Purpose
Pain, Chronic, Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Action observation therapy
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility 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
Sites / Locations
- Haydarpasa Numune Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercise
Action observation therapy and exercise
Arm Description
Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles
Outcomes
Primary Outcome Measures
Brain Hemodynamics
Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.
Pressure pain threshold
Algometer (dolorimeter) will be used to assess the pressure pain threshold.
Visual Analog Scale
Self reported pain intensity during rest and walking measured by 0-10 point scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03245073
Brief Title
Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
Official Title
Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
Arm Title
Action observation therapy and exercise
Arm Type
Experimental
Arm Description
Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles
Intervention Type
Other
Intervention Name(s)
Action observation therapy
Intervention Description
The normal human movement will be recorded and than the patients will be watched them.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Strengthening and stretching exercise programme focuses on hip and knee muscles
Primary Outcome Measure Information:
Title
Brain Hemodynamics
Description
Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.
Time Frame
6 weeks
Title
Pressure pain threshold
Description
Algometer (dolorimeter) will be used to assess the pressure pain threshold.
Time Frame
6 weeks
Title
Visual Analog Scale
Description
Self reported pain intensity during rest and walking measured by 0-10 point scale.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Western Ontario and Mcmaster Universities Osteoarthritis Index
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
Time Frame
6 weeks
Title
Kinesiophobia
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.
Time Frame
6 weeks
Title
Pain Catastrophization
Description
Pain Catastorphization Scale is a self-reported scale, and will be assessed to detect the level of pain catastrophization
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Haydarpasa Numune Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
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