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IRCT20240713062427N1 IRCT 2024-08-14 Mashhad University of Medical Sciences Effects addition of patient education to hip and knee exercise on the pain of patient with patellofemoral pain syndrome Effects addition of patient education to hip and knee exercise compared to hip and knee exercise only on the pain of patient with patellofemoral pain syndrome: A randomized clinical trial 2024-07-19 anticipated 30 Recruiting https://irct.ir/trial/77980 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: In addition to the hip and knee treatment program (control group), patients receive 8 training sessions in person by a physiotherapist. Each training session is provided one-on-one and exclusively between the patient and the physiotherapist, each training session takes about 4-6 minutes. The first session is conducted using the history and physical examination form with the aim of collecting some information about the patient's pain, location of pain, the most painful daily activity, pain during active movements of the knee (Flexion and Extension), understanding the reason for knee pain and treatment expectations. . Based on this information, special training sessions are designed according to the characteristics of each patient. For example, fear of movement and fear of pain are important psychological factors in analgesia patients, the aim is to investigate these factors during intervention sessions.The content is included in the training sessions using explanation, display of images and text. Progress will be made in each session if the therapist ensures the patient's understanding of the material discussed. The content of the training includes: 1. The cause and causes of patellar pain (for example, the active and passive structures of the knee joint, the importance of the alignment of the hip joint and its muscles) 2. Pain management strategies (for example, how to move better during activity daily exercises, prevention of knee valgus while standing, walking, going up and down the stairs, changing from sitting to standing, riding a bicycle, etc.) 3. How to modify physical activity using strategies Speed ​​and load management, for example, reducing the load or physical activities if necessary (feeling pain above 5 out of 10). 4. Answers to each patient's questions. The training content is prepared using previous studies and presented to the patient, Randomization description: Patients were divided into two groups of knee and hip muscle therapeutic exercise alone and knee and hip muscle therapeutic exercise combined with specific training by a block randomization method, using a closed envelope method by a person who is not involved in any of the intervention and evaluation stages. are divided The block random allocation method will be used with a volume of 4. All possible permutations of 4 will be listed in two groups. Permutations 1 to 6 are as follows, where A is the intervention group and B is the control group: 1-AABB 2-ABAB 3-BAAB 4-BABA 5-BBAA 6- ABBA Then, from the table of random numbers with a random starting point, 6 numbers between 1 and 6 will be randomly selected (or by using the software or sitecom (randomize.. for example, if the 6 random numbers obtained are 3 5 4 3 4 6 , it will mean that the first four people will be assigned the same as block 3, the second four people will be assigned the same as block 5, etc. In this study, blinding includes a physiotherapist colleague who performs the evaluation before and after the treatment, in addition to the person who is in charge of data analysis. Before the intervention, immediately after the end of the intervention (4 weeks) and 8 weeks (two months) after the end of the physiotherapy sessions, another physiotherapist who will not know about the way of grouping and conducting the study will evaluate the patients in terms of the desired parameters. N/A patellofemoral pain syndrome. Intervention 1: Intervention group: In addition to hip and knee exercise program (control group), patients receive 8 training sessions in person by a physiotherapist. Each training session is provided one-on-one and exclusively between the patient and the physiotherapist, each training session takes about 4 to 6 minutes. The first session is conducted using the history and physical examination form with the aim of collecting some information about the patient's pain, location of pain, the most painful daily activity, pain during active movements of the knee (Flexion and Extension), understanding the reason for knee pain and treatment expectations. Based on this information, special training sessions are designed according to the characteristics of each patient. For example, fear of movement and fear of pain are important psychological factors in analgesia patients, the aim is to investigate these factors during intervention sessions. The content is included in the training sessions using explanation, display of images and text. Progress will be made in each session if the therapist ensures the patient's understanding of the material discussed. The content of the training includes: 1. The cause and causes of patellar pain (for example, the active and passive structures of the knee joint, the importance of the alignment of the hip joint and its muscles) 2. Pain management strategies (for example, how to move better during activity (daily activities, prevention of knee valgus while standing, walking, going up and down the stairs, changing from sitting to standing, cycling, etc.) 3. How to modify physical activity using strategies speed and load management, for example, load reduction or physical activities if necessary (pain feeling above 5 out of 10) 4. Answering the questions of each patient. The content of the training is prepared using previous studies and presented to the patient. Intervention 2: Control group: Four weeks of hip and knee exercises with specific goals are divided into 3 parts: in the first week, the emphasis is on improving the control of knee and hip joint muscle movements, followed by the goal of increasing hip and knee muscle strength in the next 2 weeks, and so on. It will improve motor control. Finally, in the fourth week, strength will increase and the exercises will become more difficult using weight bearing exercises. In addition, patients will be told how to prevent lower limb abnormalities during exercise and how to perform exercises correctly by receiving feedback and performing exercises in front of a mirror. Exercises will emphasize stretching and strengthening the muscles of the knee structure (such as the quadriceps muscle, etc.) and the muscles of the hip structure (such as the muscles: Abductor Hip, Lateral rotator Hip, Extensor Hip). Force during exercise is standardized at sixty to seventy percent of RM-1, which is defined as the maximum force a person can use to complete one repetition of the exercise without pain. Maximum strength is assessed during the first treatment session and reviewed weekly for needed changes. Weight bearing exercises start with weights and based on the patient's tolerance, progress is gradually made on a weekly basis according to the patient's ability (for example: intensity, type of exercise, repetition or technique, etc.). These criteria are based on It is the protocol of previous studies. Although exercises using elastic resistance will be standardized based on the maximum resistance that each patient can use and complete 10 repetitions of the exercise, the resistance will be rechecked weekly for adequacy. Hamstring, iliotibial band and gastrocnemius are performed. Stretching Hamstrings and plantar flexors ([9] SLR in arch position), Quadriceps and Iliotibial band in side lying position) includes 30 seconds of stretching with the help of a therapist for each structure. During the training, positive and encouraging feedback is given by the therapist to encourage the participant to finish the session with as much effort as possible. The intensity of the exercises will be controlled and progressed individually by the physiotherapist. Emphasizing that the patient does not do the exercise at home should be considered. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is هنوز داده ها جمع آوری نشده است
public Neda Mostafaee
Mashhad - Azadi Square - East Gate of Ferdowsi University of Mashhad - University Campus - Faculty of Paramedical Sciences and Rehabilitation
mashhad Iran (Islamic Republic of) 9177948964 +98 916 308 4700 Neda-mostafaee@yahoo.com Mashhad University of Medical Sciences scientific Fahime Ghorbani
Vakil Abad, Sayadshirazi Boulevard, Sayad 9, No. 15, Unit 45
Mashshad Iran (Islamic Republic of) 9179686766 0913039216 fa.ghorbani.pt@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients between 18 and 45 years old. Self-reported anterior knee pain (unilateral or bilateral) when performing at least two of the following activities: prolonged sitting, squatting, kneeling, running, ascending and descending stairs, jumping and landing. Self-reported anterior knee pain with insidious onset lasting at least 3 months. Self- reported pain in the previous month should be at least 30 mm on a VAS scale of 100 mm. 18 years 45 years Both Report of anterior knee pain caused by knee injury. History report of patellar dislocation. History of surgery in any lower limb joint. Report any history of meniscus damage, ligament instability or patellar tendinopathy . History of osteoarthritis in any lower limb joint. Rheumatic or neurological disease reported by the patient. Physiotherapy treatment for patellofemoral pain during the previous 6 months. History of current or past psychosis, major depressive episode, attempted suicide, post-traumatic stress disorder, bipolar disorder, manic episode, or substance dependence. M22.2 Patellofemoral disorders Treatment - Other Treatment - Other Intervention group: In addition to hip and knee exercise program (control group), patients receive 8 training sessions in person by a physiotherapist. Each training session is provided one-on-one and exclusively between the patient and the physiotherapist, each training session takes about 4 to 6 minutes. The first session is conducted using the history and physical examination form with the aim of collecting some information about the patient's pain, location of pain, the most painful daily activity, pain during active movements of the knee (Flexion and Extension), understanding the reason for knee pain and treatment expectations. Based on this information, special training sessions are designed according to the characteristics of each patient. For example, fear of movement and fear of pain are important psychological factors in analgesia patients, the aim is to investigate these factors during intervention sessions. The content is included in the training sessions using explanation, display of images and text. Progress will be made in each session if the therapist ensures the patient's understanding of the material discussed. The content of the training includes: 1. The cause and causes of patellar pain (for example, the active and passive structures of the knee joint, the importance of the alignment of the hip joint and its muscles) 2. Pain management strategies (for example, how to move better during activity (daily activities, prevention of knee valgus while standing, walking, going up and down the stairs, changing from sitting to standing, cycling, etc.) 3. How to modify physical activity using strategies speed and load management, for example, load reduction or physical activities if necessary (pain feeling above 5 out of 10) 4. Answering the questions of each patient. The content of the training is prepared using previous studies and presented to the patient. Control group: Four weeks of hip and knee exercises with specific goals are divided into 3 parts: in the first week, the emphasis is on improving the control of knee and hip joint muscle movements, followed by the goal of increasing hip and knee muscle strength in the next 2 weeks, and so on. It will improve motor control. Finally, in the fourth week, strength will increase and the exercises will become more difficult using weight bearing exercises. In addition, patients will be told how to prevent lower limb abnormalities during exercise and how to perform exercises correctly by receiving feedback and performing exercises in front of a mirror. Exercises will emphasize stretching and strengthening the muscles of the knee structure (such as the quadriceps muscle, etc.) and the muscles of the hip structure (such as the muscles: Abductor Hip, Lateral rotator Hip, Extensor Hip). Force during exercise is standardized at sixty to seventy percent of RM-1, which is defined as the maximum force a person can use to complete one repetition of the exercise without pain. Maximum strength is assessed during the first treatment session and reviewed weekly for needed changes. Weight bearing exercises start with weights and based on the patient's tolerance, progress is gradually made on a weekly basis according to the patient's ability (for example: intensity, type of exercise, repetition or technique, etc.). These criteria are based on It is the protocol of previous studies. Although exercises using elastic resistance will be standardized based on the maximum resistance that each patient can use and complete 10 repetitions of the exercise, the resistance will be rechecked weekly for adequacy. Hamstring, iliotibial band and gastrocnemius are performed. Stretching Hamstrings and plantar flexors ([9] SLR in arch position), Quadriceps and Iliotibial band in side lying position) includes 30 seconds of stretching with the help of a therapist for each structure. During the training, positive and encouraging feedback is given by the therapist to encourage the participant to finish the session with as much effort as possible. The intensity of the exercises will be controlled and progressed individually by the physiotherapist. Emphasizing that the patient does not do the exercise at home should be considered. Visual Analog Scale (VAS). Timepoint: They will be measured at the beginning of the study (before the intervention), immediately after the end of the treatment sessions (4 weeks) and two months after the end of the sessions. Method of measurement: Visual Analogue Scale. The Pain Catastrophizing Scale (PCS). Timepoint: They will be measured at the beginning of the study (before the intervention), immediately after the end of the treatment sessions (4 weeks) and two months after the end of the sessions. Method of measurement: 13-item questionnaire of fear of pain (Pain Catastrophizing Scale). The Tampa scale for kinesiophobia (TSK). Timepoint: They will be measured at the beginning of the study (before the intervention), immediately after the end of the treatment sessions (4 weeks) and two months after the end of the sessions. Method of measurement: 17-item questionnaire of fear of movement (The Tampa scale for kinesiophobia). The result of measurement of knee functional limitation by the patient. Timepoint: They will be measured at the beginning of the study (before the intervention), immediately after the end of the treatment sessions (4 weeks) and two months after the end of the sessions. Method of measurement: 13-item questionnaire of Kujala Patellofemoral Scale. Outcome of treatment effectiveness. Timepoint: They will be measured immediately after the end of the treatment sessions (4 weeks) and two months after the end of the sessions. Method of measurement: The 7-point Likert global rating of change scale (GROC). Mashhad University of Medical Sciences Approved 2024-04-27 Research Ethics Committee of School of Paramedical Sciences and Health School School of Paramedical Sciences and Health School Mashhad Razavi Khorasan Iran (Islamic Republic of)