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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
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.
Artvin State Hospital
Artvin, Turkey (Türkiye)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-week follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-week follow-up