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IRCT20240613062111N1 IRCT 2024-08-10 Babol University of Medical Sciences The effect of Graded Sensorimotor Imagery in Patellofemoral Pain Syndrome The effect of Graded Sensorimotor Imagery on pain and disability of patients with Patellofemoral Pain Syndrome – Randomized Clinical Trial 2024-09-05 anticipated 72 Complete https://irct.ir/trial/77981 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample size of this study will be 72 people, who are randomly divided into 36 participants in the intervention group and 36 participants in the control group. The block random allocation method was designed by the methodologist using website Sealedenvelop.com. The number of considered blocks is 4. The random allocation list will only be available to the first supervisor. To conceal the random allocation process, the type of intervention (intervention group or control) will be written on 74 paper cards and placed inside opaque paper envelopes. Only the first supervisor will be aware of the corresponding codes. The order of the cards will be arranged based on the randomization list in the box. When the questioner (student/executive) declares the eligibility of the sample, the first supervisor will provide them with the paper envelope, Blinding description: The outcome assessor is a third party who is unaware of the random allocation process and the type of intervention performed. A statistician who is separate from the study process and is unaware of all the procedures that have been carried out will be used for data analysis. N/A Patellofemoral Pain Syndrome. Intervention 1: Control group: Electrotherapy: Initially, the patient receives TENS current for 20 minutes. 4 electrodes are placed around the knee at least 1 inch apart. Current settings will be 100-150 PPS pulse frequency and 50-80 microsecond pulse duration, and the current intensity will be increased to the patient's tolerance level. Manual Therapy: The therapist then applies two manual techniques: medial glide of the patella and medial tipping of the patella. Therapeutic exercise: includes stretching and strengthening exercises. a) Stretching: Stretching is performed for the hamstring, quadriceps, and gastrocnemius muscles. Stretching exercises are performed for each muscle 3 times and each time for 30 seconds. b) Strengthening: Since studies have shown that performing hip and knee exercises simultaneously have better effects compared to only knee exercises, and those hip muscles that are weakened in patients with patellofemoral pain syndrome are the abductor and extensor muscles. Exercises targeting to this group of muscles are also included in the patient's exercise program. [1- Strengthening the hip extensors and abductors (side-lying) - Strengthening the quadriceps (Quadriceps Setting – SLR – terminal knee extension) (two sets of 10-20 repetitions depending on the patient's condition)] To progress these exercises, after 2 weeks, when the patient can perform the exercises without pain and fatigue, weight-bearing exercises will continue. [2- Strengthening the hip extensor and abductor muscles (single leg on the non-involved leg) - strengthening the quadriceps muscle (standing) (three sets with 8-12 repetitions depending on the patient's condition)] these exercises are also followed for two weeks or until the patient reaches a level where they can perform these exercises correctly without pain and fatigue, we enter the next stage. 3- Lunge - Standing wall slide (three sets with 8-12 repetitions depending on the patient's condition)]. The frequency of all exercises is twice a day. Intervention 2: Intervention group: In addition to the treatment of the control group, patients in the intervention group also receive the following interventions. These exercises will be performed three days a week (every other day) under the supervision of a therapist. In the first two weeks, they receive left and right discrimination exercises. For this exercise, the Recognise™ Knee application is used. In this exercise, 20 images (each image lasts for five seconds) are randomly shown to the person, and they must identify whether it is the right or left knee without focusing on their knees. At first, the patient is explained about how to perform this intervention, and after making sure that they are fully justified, the intervention begins. Basic, Vanilla and Context modes of this application are used to progress the practice from simple to complex. At each level, they can enter the next level by achieving more than 80% accuracy and a response time of 1.5-2.5 seconds. This exercise will be done once a day and every other day under the supervision of a therapist. In the second two weeks, motor imagery exercises are performed. To perform this exercise, participants must imagine themselves (not someone else) in a particular position or movement. In order to do this, a video of the desired activity will be shown to the patient, they are asked to mentally review it and focus on performing the movement correctly. This exercise starts with activities that the patient feels more comfortable with and progresses towards activities that are more difficult for them. Initially, to avoid provoking pain, they are asked to imagine the non-involved limb in the said position or movement, and then perform this mental exercise for the involved side. Positions that the patient is asked to visualize include: sitting with knees bent, walking, descending stairs, ascending stairs, squatting, and running. Furthermore, these exercises begin in a quiet environment and can later be performed in a more crowded environment. Each movement is visualized 10 times in five double sets with 30 seconds of rest between each set. Additionally, in the second two weeks, we also start Graphesthesia to improve the patient's sensory performance. Patients are asked to keep their eyes closed and use their sense of touch to recognize what is randomly written on the skin around the knee. Initially, we start with letters and single-digit numbers written in large size at a slow writing speed. The progression of this exercise involves increasing the writing speed, reducing the size of the written characters, and creating combinations of up to three letters. In the third two weeks, we use mirror for visual feedback. For this purpose, while the patient is sitting on the edge of a bed, we place a portable mirror between his legs so that the painful limb is behind the mirror and the other limb is in front of it. Then we ask the patient to lean forward to see the reflection of the leg in front of the mirror and focus on it until he feels comfortable. Then we ask him to extend both legs; the painful limb only to its point of pain and the non-painful limb to its full range. This exercise continues until the patient achieves full extension in the painful leg. Then we use weights to progress the exercise. Also, the patient performs lunge and standing wall slide exercises in front of the mirror. This exercise lasts at least 5 and at most 10 minutes. Yes - There is a plan to make this available What will be shared: Data including main, confounder and demographic outcomes are shared while maintaining the principle of anonymity. When: Access to the data will begin after the results are published. To whom: Researchers working in the relevant field. Conditions: Data from this study are accessible for use in systematic review articles. Where to obtain: Requests for data should be sent to the e-mail of principal investigator, Dr. Maryam Abbaszadeh, at m.abbaszadeh@mubabol.ac.ir. How to obtain: After receiving a data request, his request will be reviewed by principal investigator, and if eligible, the requested information will be sent to the applicant. Comments:
public Maryam Abbaszadeh-Amirdehi
Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran
Babol Iran (Islamic Republic of) 4774547176 +98 11 3219 4941 m.abbaszadeh@mubabol.ac.ir Babol University of Medical Sciences scientific Maryam Abbaszadeh-Amirdehi
Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran
Babol Iran (Islamic Republic of) 4774547176 +98 11 3219 4941 m.abbaszadeh@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Age 18-45 years Increase in pain with at least two of the following movements: squatting, going up and down stairs, running, prolonged sitting, kneeling, jumping and landing Positive Clark's test (method: guide the patient's patella downwards. Then ask the patient to perform quadriceps contraction. The presence or exacerbation of pain is considered a positive test.) The patient has had pain in front of his knee for at least the last 3 months. The intensity of the patient's pain based on the VAS scale should be at least 3.5/10 and at most 7.4/10. They have not received physiotherapy in the past 6 months. 18 years 45 years Both History of trauma, meniscus or ligament injury, or patellar tendinopathy Osteoarthritis in any of the lower limb joints History of Rheumatic or neurological diseases Lower back pain with/without referred pain to the leg History of surgery in any of the lower limbs Cognitive and psychological imbalance affecting the individual's functioning and perception. M22.4 Chondromalacia patellae Rehabilitation Rehabilitation Control group: Electrotherapy: Initially, the patient receives TENS current for 20 minutes. 4 electrodes are placed around the knee at least 1 inch apart. Current settings will be 100-150 PPS pulse frequency and 50-80 microsecond pulse duration, and the current intensity will be increased to the patient's tolerance level. Manual Therapy: The therapist then applies two manual techniques: medial glide of the patella and medial tipping of the patella. Therapeutic exercise: includes stretching and strengthening exercises. a) Stretching: Stretching is performed for the hamstring, quadriceps, and gastrocnemius muscles. Stretching exercises are performed for each muscle 3 times and each time for 30 seconds. b) Strengthening: Since studies have shown that performing hip and knee exercises simultaneously have better effects compared to only knee exercises, and those hip muscles that are weakened in patients with patellofemoral pain syndrome are the abductor and extensor muscles. Exercises targeting to this group of muscles are also included in the patient's exercise program. [1- Strengthening the hip extensors and abductors (side-lying) - Strengthening the quadriceps (Quadriceps Setting – SLR – terminal knee extension) (two sets of 10-20 repetitions depending on the patient's condition)] To progress these exercises, after 2 weeks, when the patient can perform the exercises without pain and fatigue, weight-bearing exercises will continue. [2- Strengthening the hip extensor and abductor muscles (single leg on the non-involved leg) - strengthening the quadriceps muscle (standing) (three sets with 8-12 repetitions depending on the patient's condition)] these exercises are also followed for two weeks or until the patient reaches a level where they can perform these exercises correctly without pain and fatigue, we enter the next stage. 3- Lunge - Standing wall slide (three sets with 8-12 repetitions depending on the patient's condition)]. The frequency of all exercises is twice a day. Intervention group: In addition to the treatment of the control group, patients in the intervention group also receive the following interventions. These exercises will be performed three days a week (every other day) under the supervision of a therapist. In the first two weeks, they receive left and right discrimination exercises. For this exercise, the Recognise™ Knee application is used. In this exercise, 20 images (each image lasts for five seconds) are randomly shown to the person, and they must identify whether it is the right or left knee without focusing on their knees. At first, the patient is explained about how to perform this intervention, and after making sure that they are fully justified, the intervention begins. Basic, Vanilla and Context modes of this application are used to progress the practice from simple to complex. At each level, they can enter the next level by achieving more than 80% accuracy and a response time of 1.5-2.5 seconds. This exercise will be done once a day and every other day under the supervision of a therapist. In the second two weeks, motor imagery exercises are performed. To perform this exercise, participants must imagine themselves (not someone else) in a particular position or movement. In order to do this, a video of the desired activity will be shown to the patient, they are asked to mentally review it and focus on performing the movement correctly. This exercise starts with activities that the patient feels more comfortable with and progresses towards activities that are more difficult for them. Initially, to avoid provoking pain, they are asked to imagine the non-involved limb in the said position or movement, and then perform this mental exercise for the involved side. Positions that the patient is asked to visualize include: sitting with knees bent, walking, descending stairs, ascending stairs, squatting, and running. Furthermore, these exercises begin in a quiet environment and can later be performed in a more crowded environment. Each movement is visualized 10 times in five double sets with 30 seconds of rest between each set. Additionally, in the second two weeks, we also start Graphesthesia to improve the patient's sensory performance. Patients are asked to keep their eyes closed and use their sense of touch to recognize what is randomly written on the skin around the knee. Initially, we start with letters and single-digit numbers written in large size at a slow writing speed. The progression of this exercise involves increasing the writing speed, reducing the size of the written characters, and creating combinations of up to three letters. In the third two weeks, we use mirror for visual feedback. For this purpose, while the patient is sitting on the edge of a bed, we place a portable mirror between his legs so that the painful limb is behind the mirror and the other limb is in front of it. Then we ask the patient to lean forward to see the reflection of the leg in front of the mirror and focus on it until he feels comfortable. Then we ask him to extend both legs; the painful limb only to its point of pain and the non-painful limb to its full range. This exercise continues until the patient achieves full extension in the painful leg. Then we use weights to progress the exercise. Also, the patient performs lunge and standing wall slide exercises in front of the mirror. This exercise lasts at least 5 and at most 10 minutes. Pain Intensity. Timepoint: Before starting and after the end of 6 weeks of intervention. Method of measurement: Visual Analogue Scale. Disability. Timepoint: before the beginning and after the end of 6 weeks of intervention. Method of measurement: Anterior Knee Pain Questionnaire (Kujala). Tactile Acuity. Timepoint: before the beginning and after the end of 6 weeks of intervention. Method of measurement: caliper. Central Sensitization. Timepoint: before the beginning and after the end of 6 weeks of intervention. Method of measurement: Central Sensitization Inventory Questionnaire. Babol University of Medical Sciences Approved 2024-06-10 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj afrooz Ave. Babol Mazandaran Iran (Islamic Republic of)