]>
IRCT20180804040685N4 IRCT 2022-02-09 Tehran University of Medical Sciences Evaluation of the effectiveness of biofeedback in patients with patellofemoral syndrome Evaluation of the effect of biofeedback on pain relief and function in patients with patellofemoral syndrome 2021-11-22 anticipated 60 Complete https://irct.ir/trial/60227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method will be used to maintain the balance between the intervention and control groups. In each block, 6 people will be in the study group as 3 people and 3 people in the control group. How to assign people in each group will be done using a table of random numbers read from top to bottom, Blinding description: According to the patients are in two groups, A and B; group A are patients who after connecting the biofeedback device are taught how to perform exercises and how the device works by changing shapes and playing games. Group B are patients who, after connecting the biofeedback device are taught only how to do exercise and do not see how the device works, and only a game is being played in front of them that they do not know is related to exercise and muscle contraction. The device is connected to patients by a trained occupational therapist who is aware of how patients are coded according to the randomization formula. Another occupational therapist performs an initial evaluation of the table of variables in patients before and after biofeedback, knowing only the names of the patients and the patient's belonging to group (A or B). Therefore, the study is the double blind. N/A patellofemoral pain syndrome. Intervention 1: Intervention group: Informed consent will be obtained from patients before entering the study. Demographic information of all patients including age, sex, BMI, duration of the disease is first collected and goniometer tests, VAS and KUJALA and SF36 questionnaires and quadriceps muscle range of motion and thigh diameter are evaluated before rehabilitation. Then, to strengthen the stabilizer muscles of the knee, biofeedback is performed three times a week for 4 weeks with 30-minute sessions with the supervision of an occupational therapist. Immediately after 3 months of the rehabilitation program, the tests and the level of satisfaction are evaluated again. The evaluator and the patients are not informed about the groups and divisions. As a result, double-blinded randomization is performed for study. Intervention 2: Control group: All assessments and rehabilitation interventions are the same as the intervention group. The only difference is the use of sham-biofeedback. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient privacy
public Hamid Reza Fateh
Jalal-Al-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8940 2110 hr-fateh@tums.ac.ir Tehran University of Medical Sciences scientific Hamid Reza Fateh
Jalal Ale-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2110 hr-fateh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of unilateral patellofemoral syndrome based on at least 5 of 7 symptoms There is no evidence of other injuries intra- and extra-arthicular of knee joint, which can be determined by physical examination and radiographic evaluation Normal range of motion of the knee as measured by a goniometer No history of knee trauma, intra-articular injection or surgery Do not use nonsteroidal anti-inflammatory drugs for 15 days before starting treatment Full collaboration to conduct the study 18 years no limit Both Having a pain score less than 3 on a numerical scale History of knee locking and patella dislocation Osteoarthritis or arthritis of the knee and any abnormal radiography of the knee Joint infection and knee ligamentous laxity History of previous knee physiotherapy, knee surgery, and knee injuries and bruises Genu valgum, Osgood-Schlatter disease, and any other pathological disease Any other treatment for patellofemoral syndrome during the study M22.2X Patellofemoral disorders Rehabilitation Rehabilitation Intervention group: Informed consent will be obtained from patients before entering the study. Demographic information of all patients including age, sex, BMI, duration of the disease is first collected and goniometer tests, VAS and KUJALA and SF36 questionnaires and quadriceps muscle range of motion and thigh diameter are evaluated before rehabilitation. Then, to strengthen the stabilizer muscles of the knee, biofeedback is performed three times a week for 4 weeks with 30-minute sessions with the supervision of an occupational therapist. Immediately after 3 months of the rehabilitation program, the tests and the level of satisfaction are evaluated again. The evaluator and the patients are not informed about the groups and divisions. As a result, double-blinded randomization is performed for study. Control group: All assessments and rehabilitation interventions are the same as the intervention group. The only difference is the use of sham-biofeedback Pain intensity. Timepoint: Before the intervention, immediately and 3 months after the intervention. Method of measurement: Visual Analog Scale. Satisfaction rate. Timepoint: Immediately and three months after the intervention. Method of measurement: Satisfaction rate questionnaire. Quality of life. Timepoint: Before the intervention, immediately and 3 months after the intervention. Method of measurement: SF36 Questionnaire. Daily performance. Timepoint: Before the intervention, immediately and 3 months after the intervention. Method of measurement: Kujala scale. Tehran University of Medical Sciences Approved 2021-11-10 Ethics committee of Tehran University of Medical Sciences Jalal Ale-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)