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Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Action Observation Therapy, Functional Near Infared Spectroscopy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Action observation therapy
Exercise
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • MMSE>21
  • Chronic knee pain (VAS score>5)
  • Right dominant
  • Unilateral knee pain

Exclusion Criteria:

  • Pain characteristics such as the presence of a rheumatologic disease other than knee osteoarthritis, lumbar radiculopathy, systemic inflammatory disease, diabetic neuropathy, problems similar to knee osteoarthritis,
  • Hearing or vision problems,
  • Injection therapy involving the knee region within the last 6 months,
  • Surgical operation involving the knee region
  • Psychiatric problems and anti-depressant usage

Sites / Locations

  • Özgül Öztürk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action observation therapy and exercise

Exercise

Arm Description

Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles

Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises

Outcomes

Primary Outcome Measures

Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)
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)
Pain Level
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.
Pressure pain threshold
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.

Secondary Outcome Measures

Kinesiophobia
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.
Western Ontario and Mcmaster Universities Osteoarthritis Index
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.
Muscle strength
Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.
Range of motion
Knee range of motion will be evaluated by digital goniometer. Knee flexion, knee extension, ankle dorsi and plantar flexion will be assessed.

Full Information

First Posted
December 28, 2018
Last Updated
July 15, 2022
Sponsor
Acibadem University
Collaborators
Haydarpasa Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03792165
Brief Title
Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis
Official Title
Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
Collaborators
Haydarpasa Numune Training and Research Hospital

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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Action Observation Therapy, Functional Near Infared Spectroscopy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

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
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
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
Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)
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)
Time Frame
6 weeks
Title
Pain Level
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.
Time Frame
6 weeks
Title
Pressure pain threshold
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Kinesiophobia
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.
Time Frame
6 weeks
Title
Western Ontario and Mcmaster Universities Osteoarthritis Index
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.
Time Frame
6 weeks
Title
Muscle strength
Description
Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.
Time Frame
6 weeks
Title
Range of motion
Description
Knee range of motion will be evaluated by digital goniometer. Knee flexion, knee extension, ankle dorsi and plantar flexion will be assessed.
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: MMSE>21 Chronic knee pain (VAS score>5) Right dominant Unilateral knee pain Exclusion Criteria: Pain characteristics such as the presence of a rheumatologic disease other than knee osteoarthritis, lumbar radiculopathy, systemic inflammatory disease, diabetic neuropathy, problems similar to knee osteoarthritis, Hearing or vision problems, Injection therapy involving the knee region within the last 6 months, Surgical operation involving the knee region Psychiatric problems and anti-depressant usage
Facility Information:
Facility Name
Özgül Öztürk
City
İstanbul
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis

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