Knee OsteoarthritisNCT03792165
Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis
A study testing Action observation therapy and Exercise in people with Knee Osteoarthritis and Action Observation Therapy, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Action Observation Therapy, Functional Near Infared Spectroscopy
- What is being tested?
- Action observation therapy and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2019to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MMSE>21
- Chronic knee pain (VAS score>5)
- Right dominant
- Unilateral knee pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Action Observation Therapy, Functional Near Infared Spectroscopy, Exercise
- Being tested
- Action observation therapy, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation therapyOther
The normal human movement will be recorded and than the patients will be watched them.
ExerciseOther
Strengthening and stretching exercise programme focuses on hip and knee muscles
| Study group | Role | What they receive |
|---|---|---|
| Action observation therapy and exercise | Experimental | Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles Receives: Other: Action observation therapy; Other: Exercise |
| Exercise | Active comparator | Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Muscle strength
Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start11 Feb 2019
- Primary completion8 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792165
- Sponsor's protocol ID
- ATADEK 2017/8
- Status last verified
- Jul 2022
- First submitted
- 28 Dec 2018
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03792165
- Acronym / sponsor ID
- ATADEK 2017/8
- Conditions
- Knee Osteoarthritis, Action Observation Therapy, Functional Near Infared Spectroscopy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation therapy and exercise | Experimental | Other: Action observation therapy, Other: ExerciseVideo of normal human movement and Strengthening and stretching exercises for hip and knee muscles |
| Exercise | Active comparator | Other: ExerciseStrengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MMSE>21
- Chronic knee pain (VAS score>5)
- Right dominant
- Unilateral knee pain
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action observation therapyThe normal human movement will be recorded and than the patients will be watched them. | Other | Action observation therapy and exercise |
| ExerciseStrengthening and stretching exercise programme focuses on hip and knee muscles | Other | Action observation therapy and exercise, Exercise |
Primary outcome
Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
4 secondary outcomes
Kinesiophobia
Time frame: 6 weeks
Western Ontario and Mcmaster Universities Osteoarthritis Index
Time frame: 6 weeks
Muscle strength
Time frame: 6 weeks
Range of motion
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation therapy and Exercise in people with Knee Osteoarthritis and Action Observation Therapy, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.