Knee OsteoarthritisNCT05925517
The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis
A study testing Graded Motor Imagery (GMI), Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional Physiotherapy Program in people with Knee Osteoarthritis and Limitation, Mobility, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Limitation, Mobility
- What is being tested?
- Graded Motor Imagery (GMI), Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 31 Mar 2024
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
- Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
- Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
- Age between 45 and 64 years
- Residing in the city where the study is conducted
- Ability to walk independently
- Presence of limitations in knee range of motion (ROM)
- Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III
Who cannot join
- Patients who are unwilling to participate in the study
- Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
- Presence of a neuromuscular disease
- History of intra-articular injections in the past 6 months
- Patients undergoing medication changes
- Presence of any chronic illness that would hinder participation in the treatment program
Show all 9Show fewer
- Participation in a physiotherapy program for OA in the last 12 weeks
- Movement limitations or limb deficiency in the contralateral lower extremity
- Presence of visual or hearing problems that would affect treatment adherence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial
The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.
Read the detailed description
46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.
- Conditions
- Knee Osteoarthritis, Limitation, Mobility
- Being tested
- Graded Motor Imagery (GMI), Transcutaneous Electrical Nerve Stimulation (TENS), Conventional Physiotherapy Program, Home Exercise Protocol
- Keywords
- Pain, Knee Joint, Exercise, Range of Motion, Muscle Strength
- Medical subject headings
- Osteoarthritis, Knee, Mobility Limitation, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor Imagery (GMI)Other
Also called GMI
GMI includes three stages. Each session will be 30 minutes, and the GMI program will span over 8 weeks. The first 3 weeks will focus on lateralization, followed by 3 weeks of motor imagery, and the final 2 weeks will involve mirror therapy.
Lateralization: Patients will be asked to differentiate whether the extremities shown in the Recognise™ Knee application belong to the right or left side of their body.
Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Knee application and then returning to the starting position.
Mirror Therapy: Using a mirror measuring 90x60 cm² placed between the lower extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities.
Transcutaneous Electrical Nerve Stimulation (TENS)Other
Also called TENS
Application will be performed using a TENS device and four separate 2 × 2 inch self-adhesive electrodes. The current will be applied to the most painful area of the affected knee. The four self-adhesive electrodes will be positioned in a square pattern, approximately 5 cm apart, centered over the pain point. Conventional TENS will be applied for 30 minutes at a frequency of 100 Hz, pulse width of 100 μs, and intensity below 10% of the motor threshold.
Conventional Physiotherapy ProgramOther
The routine 60-minute program for OA patients in conventional physiotherapy includes warming up, core stability, pelvic and hip stability, gluteus medius strengthening, knee control and stability (knee flexion and extension control, lunge exercises), knee strengthening exercises (wall-assisted leg press with a ball, step-ups with elastic bands), and functional exercises.
Home Exercise ProtocolOther
The home exercises will include a warm-up consisting of a 10-minute walk at a normal pace on a flat surface while gently stretching the hamstring and calf muscles. The exercises will also involve straight leg raises, terminal knee extension, isometric contractions of the quadriceps femoris and adductor muscles using a pillow for support, toe raises, single-leg standing, toe taps, and quadriceps strengthening exercises included in the session.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery | Experimental | Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, conventional physiotherapy, and home exercises. Receives: Other: Graded Motor Imagery (GMI); Other: Conventional Physiotherapy Program; Other: Home Exercise Protocol |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Active comparator | Each patient in the Transcutaneous Electrical Nerve Stimulation group will receive a treatment protocol consisting of Transcutaneous Electrical Nerve Stimulation, conventional physiotherapy, and home exercises. Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Conventional Physiotherapy Program; Other: Home Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Measured: Baseline
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Measured: After the 8-week intervention
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Measured: 6-week follow-up
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Measured: Baseline
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Measured: After the 8-week intervention
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Measured: 6-week follow-up
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Measured: Baseline
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Measured: After the 8-week intervention
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Measured: 6-week follow-up
Secondary outcomes (15)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Measured: Baseline
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Measured: After the 8-week intervention
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Measured: 6-week follow-up
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Measured: Baseline
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Measured: After the 8-week intervention
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Measured: 6-week follow-up
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Measured: Baseline
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Measured: After the 8-week intervention
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Measured: 6-week follow-up
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Measured: Baseline
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Measured: After the 8-week intervention
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Measured: 6-week follow-up
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Measured: Baseline
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Measured: After the 8-week intervention
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Measured: 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jul 2023
- Primary completion15 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Model description
- In this prospective study, two treatment groups were formed to receive GMI and TENS.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Zeynep Yıldız Kızkın, Artvin Coruh University
- Investigators
- Zeynep Yıldız Kızkın, PhD, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925517
- Sponsor's protocol ID
- Graded Motor Imagery
- Status last verified
- Oct 2024
- First submitted
- 22 Jun 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kizkin ZY, Oguz S, Ak S. The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Comparative Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):534-543. doi: 10.1097/PHM.0000000000002663. Epub 2024 Nov 28.
PubMed 39642317
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05925517
- Acronym / sponsor ID
- Graded Motor Imagery
- Conditions
- Knee Osteoarthritis, Limitation, Mobility
- Keywords
- Pain, Knee Joint, Exercise, Range of Motion, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Jun 2023 (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 aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.
Detailed description
46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this prospective study, two treatment groups were formed to receive GMI and TENS.
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery | Experimental | Other: Graded Motor Imagery (GMI), Other: Conventional Physiotherapy Program, Other: Home Exercise ProtocolEach patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, conventional physiotherapy, and home exercises. |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS), Other: Conventional Physiotherapy Program, Other: Home Exercise ProtocolEach patient in the Transcutaneous Electrical Nerve Stimulation group will receive a treatment protocol consisting of Transcutaneous Electrical Nerve Stimulation, conventional physiotherapy, and home exercises. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
- Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
- Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
- Age between 45 and 64 years
- Residing in the city where the study is conducted
Key exclusion criteria (9 listed)
- Patients who are unwilling to participate in the study
- Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
- Presence of a neuromuscular disease
- History of intra-articular injections in the past 6 months
- Patients undergoing medication changes
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 |
|---|---|---|
| Graded Motor Imagery (GMI)Also: GMIGMI includes three stages. Each session will be 30 minutes, and the GMI program will span over 8 weeks. The first 3 weeks will focus on lateralization, followed by 3 weeks of motor imagery, and the final 2 weeks will involve mirror therapy. Lateralization: Patients will be asked to differentiate whether the extremities shown in the Recognise™ Knee application belong to the right or left side of their body. Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Knee application and then returning to the starting position. Mirror Therapy: Using a mirror measuring 90x60 cm² placed between the lower extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities. | Other | Graded Motor Imagery |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: TENSApplication will be performed using a TENS device and four separate 2 × 2 inch self-adhesive electrodes. The current will be applied to the most painful area of the affected knee. The four self-adhesive electrodes will be positioned in a square pattern, approximately 5 cm apart, centered over the pain point. Conventional TENS will be applied for 30 minutes at a frequency of 100 Hz, pulse width of 100 μs, and intensity below 10% of the motor threshold. | Other | Transcutaneous Electrical Nerve Stimulation (TENS) |
| Conventional Physiotherapy ProgramThe routine 60-minute program for OA patients in conventional physiotherapy includes warming up, core stability, pelvic and hip stability, gluteus medius strengthening, knee control and stability (knee flexion and extension control, lunge exercises), knee strengthening exercises (wall-assisted leg press with a ball, step-ups with elastic bands), and functional exercises. | Other | Graded Motor Imagery, Transcutaneous Electrical Nerve Stimulation (TENS) |
| Home Exercise ProtocolThe home exercises will include a warm-up consisting of a 10-minute walk at a normal pace on a flat surface while gently stretching the hamstring and calf muscles. The exercises will also involve straight leg raises, terminal knee extension, isometric contractions of the quadriceps femoris and adductor muscles using a pillow for support, toe raises, single-leg standing, toe taps, and quadriceps strengthening exercises included in the session. | Other | Graded Motor Imagery, Transcutaneous Electrical Nerve Stimulation (TENS) |
Primary outcome
Pain Intensity
Time frame: Baseline
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Intensity
Time frame: After the 8-week intervention
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Intensity
Time frame: 6-week follow-up
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Pressure Threshold
Time frame: Baseline
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Pain Pressure Threshold
Time frame: After the 8-week intervention
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Pain Pressure Threshold
Time frame: 6-week follow-up
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
WOMAC Pain Subscale
Time frame: Baseline
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
WOMAC Pain Subscale
Time frame: After the 8-week intervention
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
WOMAC Pain Subscale
Time frame: 6-week follow-up
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
15 secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Baseline
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: After the 8-week intervention
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: 6-week follow-up
Range of Motion (ROM)
Time frame: Baseline
Range of Motion (ROM)
Time frame: After the 8-week intervention
Range of Motion (ROM)
Time frame: 6-week follow-up
Isometric Muscle Strength
Time frame: Baseline
Isometric Muscle Strength
Time frame: After the 8-week intervention
Isometric Muscle Strength
Time frame: 6-week follow-up
Mini Mental State Examination
Time frame: Baseline
Mini Mental State Examination
Time frame: After the 8-week intervention
Mini Mental State Examination
Time frame: 6-week follow-up
Timed Get Up and Go Test (TUG)
Time frame: Baseline
Timed Get Up and Go Test (TUG)
Time frame: After the 8-week intervention
Timed Get Up and Go Test (TUG)
Time frame: 6-week follow-up
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 29 Oct 2024.
- Derived from this study: PubMed 39642317Kizkin ZY, Oguz S, Ak S. The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Comparative Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):534-543. doi: 10.1097/PHM.0000000000002663. Epub 2024 Nov 28.
- Individual participant dataSharing planned: No
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Zeynep Yıldız Kızkın, PhD principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery (GMI), Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional Physiotherapy Program in people with Knee Osteoarthritis and Limitation, Mobility, run by Artvin Coruh 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 8 inclusion and 9 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 29 Oct 2024. 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?
Pain Intensity (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925517, which also lists 1 linked publication.
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 29 Oct 2024.