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IRCT20221129056656N1 IRCT 2022-12-28 University of social welfare and rehabilitation sciences Effectiveness Evaluation of Lumbar Stabilization Exercise Based on Telerehabilitation in Nonspecific Chronic Low Back Pain Effectiveness Evaluation of Lumbar Stabilization Exercise Based on Telerehabilitation in Nonspecific Chronic Low Back Pain 2023-01-05 anticipated 30 Complete https://irct.ir/trial/67231 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible volunteers will randomly assigned to either "intervention" or "control" Simple Random Sampling will be done by picking between two choice "Intervention" and "Control". N/A Nonspecific Chronic Low Back Pain. Intervention 1: Intervention group 1: Patients are asked to maintain the contraction of the stabilizing muscles of the lumbar region for 5 to 10 seconds and do 10 times with a 10-second rest between each repetition. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention 2: Intervention group 2: In the supine, the patient contracts the stabilizing muscles of the lower back and while maintaining this contraction, slides the heel of one leg on the bed until the knee is completely straightened. Then he returns the leg to the first position and performs the movement with the opposite leg, after 10 seconds of rest, he follows this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention 3: Intervention group 3: In supine, the patient has contracted the stabilizing muscles of the lumbar region and very slowly straightened one leg, and after obtaining the full range of knee extension and placing the anterior superior Iliac spine with the patella in line with the ground (between 7 and 10 cm above the surface of the bed) the extension of the hip joint is stopped and maintained for 5 seconds. Then it returns to the initial position and the movement is performed with the lower limb of the opposite side, after 10 seconds of rest, it performs this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention 4: Intervention group 4: The patient sits on a stool with his back to the wall so that the soles of his feet are on the floor, the cushion of the biofeedback device is placed between the lumbar arch of the patient and the wall, the patient performs the contraction of the stabilizing muscles of the lumbar region and maintains this movement for 5 to 10 seconds, 10 times. Repeats with a 10-second rest. Then while the knee is relaxed and bent he raise the thigh up to 45-degree angle of hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention 5: Intervention group 5: The patient stands straight with his back against the wall while the biofeedback pillow is placed between the lumbar arch and the wall, first he contracts the stabilizing muscles of the lumbar region and maintains it for 5 to 10 seconds. Perform this movement 10 times with 10 seconds rest between repetitions. Then, keeping the contraction, he raises the lower limb to a 90-degree knee and hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention 6: Control group 1: Patients are asked to maintain the contraction of the stabilizing muscles of the lumbar region for 5 to 10 seconds and do 10 times with a 10-second rest between each repetition. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Intervention 7: Control group 2: In the supine, the patient contracts the stabilizing muscles of the lower back and while maintaining this contraction, slides the heel of one leg on the bed until the knee is completely straightened. Then he returns the leg to the first position and performs the movement with the opposite leg, after 10 seconds of rest, he follows this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Intervention 8: Control group 3: In supine, the patient has contracted the stabilizing muscles of the lumbar region and very slowly straightened one leg, and after obtaining the full range of knee extension and placing the anterior superior Iliac spine with the patella in line with the ground (between 7 and 10 cm above the surface of the bed) the extension of the hip joint is stopped and maintained for 5 seconds. Then it returns to the initial position and the movement is performed with the lower limb of the opposite side, after 10 seconds of rest, it performs this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Intervention 9: Control group 4: The patient sits on a stool with his back to the wall so that the soles of his feet are on the floor, the cushion of the biofeedback device is placed between the lumbar arch of the patient and the wall, the patient performs the contraction of the stabilizing muscles of the lumbar region and maintains this movement for 5 to 10 seconds, 10 times. Repeats with a 10-second rest. Then while the knee is relaxed and bent he raise the thigh up to 45-degree angle of hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Intervention 10: Control group 5: The patient stands straight with his back against the wall while the biofeedback pillow is placed between the lumbar arch and the wall, first he contracts the stabilizing muscles of the lumbar region and maintains it for 5 to 10 seconds. Perform this movement 10 times with 10 seconds rest between repetitions. Then, keeping the contraction, he raises the lower limb to a 90-degree knee and hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect the privacy of the patients participating in the research.
public Shima Karimi
Unit 7, No. 32, Golestan St., Cent. JanatAbad
Tehran Iran (Islamic Republic of) 1475636756 +98 21 4462 3852 lindakarimi80@yahoo.com University of social welfare and rehabilitation sciences scientific Shima Karimi
Unit 7, No. 32, Golestan St., Cent. JanatAbad
Tehran Iran (Islamic Republic of) 1475636756 +98 21 4462 3852 lindakarimi80@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) People between 20-60 years old, suffer Nonspecific Chronic Low Back Pain Had back pain at least 12 week before research, or suffered back pain at least 3 times, each one more than one week, in one year before research, Know how to use PC or Laptop 20 years 60 years Both History of spinal, pelvic, lower limb fracture in last year History of any surgery in the spine area History of neuromuscular diseases History of systemic diseases such as rheumatism, joint tuberculosis, diabetes along with neuropathy Acute intervertebral disc herniation in the lumbar region The presence of diffuse and radicular pains in the lower limbs as well as nerve and sensory disorders such as tingling, murmur, etc. in the lower limbs and especially in dermatomes related to the nerve roots Existence of anatomical problems in back and hip radiographs of patients The presence of spondylolisthesis and spondylolysis The presence of acute back pain caused by trauma during the research period (According to the patient's self-report) Patients addicted to alcohol and drugs (Based on the patient's self-report in the questionnaire) Existence of severe pain during the tests so that the pain becomes the cause of movement limitation in performing the measurements and disrupts their correct evaluation. For this purpose, the pain intensity during the tests should be below 7 VAS scale Patients who have done physiotherapy treatment for their back pain in the last 6 months Pregnant women at any stage of pregnancy Obesity (body mass index above 30) History of any shortness of breath based on the public health questionnaire History of any pain, dislocation or fracture in the hip joint area based on the general health questionnaire (regardless of time) History of any injury to the back and lower limbs in the last 3 months based on the general health questionnaire People who participate in preparation programs for competitive sports (training more than 3 days per week) M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Patients are asked to maintain the contraction of the stabilizing muscles of the lumbar region for 5 to 10 seconds and do 10 times with a 10-second rest between each repetition. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention group 2: In the supine, the patient contracts the stabilizing muscles of the lower back and while maintaining this contraction, slides the heel of one leg on the bed until the knee is completely straightened. Then he returns the leg to the first position and performs the movement with the opposite leg, after 10 seconds of rest, he follows this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention group 3: In supine, the patient has contracted the stabilizing muscles of the lumbar region and very slowly straightened one leg, and after obtaining the full range of knee extension and placing the anterior superior Iliac spine with the patella in line with the ground (between 7 and 10 cm above the surface of the bed) the extension of the hip joint is stopped and maintained for 5 seconds. Then it returns to the initial position and the movement is performed with the lower limb of the opposite side, after 10 seconds of rest, it performs this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention group 4: The patient sits on a stool with his back to the wall so that the soles of his feet are on the floor, the cushion of the biofeedback device is placed between the lumbar arch of the patient and the wall, the patient performs the contraction of the stabilizing muscles of the lumbar region and maintains this movement for 5 to 10 seconds, 10 times. Repeats with a 10-second rest. Then while the knee is relaxed and bent he raise the thigh up to 45-degree angle of hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Intervention group 5: The patient stands straight with his back against the wall while the biofeedback pillow is placed between the lumbar arch and the wall, first he contracts the stabilizing muscles of the lumbar region and maintains it for 5 to 10 seconds. Perform this movement 10 times with 10 seconds rest between repetitions. Then, keeping the contraction, he raises the lower limb to a 90-degree knee and hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device at home and controlled remotely by the researcher with the help of AnyDesk software. Control group 1: Patients are asked to maintain the contraction of the stabilizing muscles of the lumbar region for 5 to 10 seconds and do 10 times with a 10-second rest between each repetition. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Control group 2: In the supine, the patient contracts the stabilizing muscles of the lower back and while maintaining this contraction, slides the heel of one leg on the bed until the knee is completely straightened. Then he returns the leg to the first position and performs the movement with the opposite leg, after 10 seconds of rest, he follows this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Control group 3: In supine, the patient has contracted the stabilizing muscles of the lumbar region and very slowly straightened one leg, and after obtaining the full range of knee extension and placing the anterior superior Iliac spine with the patella in line with the ground (between 7 and 10 cm above the surface of the bed) the extension of the hip joint is stopped and maintained for 5 seconds. Then it returns to the initial position and the movement is performed with the lower limb of the opposite side, after 10 seconds of rest, it performs this movement up to 10 repetitions. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Control group 4: The patient sits on a stool with his back to the wall so that the soles of his feet are on the floor, the cushion of the biofeedback device is placed between the lumbar arch of the patient and the wall, the patient performs the contraction of the stabilizing muscles of the lumbar region and maintains this movement for 5 to 10 seconds, 10 times. Repeats with a 10-second rest. Then while the knee is relaxed and bent he raise the thigh up to 45-degree angle of hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Control group 5: The patient stands straight with his back against the wall while the biofeedback pillow is placed between the lumbar arch and the wall, first he contracts the stabilizing muscles of the lumbar region and maintains it for 5 to 10 seconds. Perform this movement 10 times with 10 seconds rest between repetitions. Then, keeping the contraction, he raises the lower limb to a 90-degree knee and hip joint. Then repeat with other leg for 10 times with a 10-second rest. This exercise is performed using a pressure biofeedback device in the clinic under the direct supervision of the researcher. Pain Intensity: It is an unpleasant sensory and emotional experience that occurs with real or potential tissue damage or is expressed as such damage. Therefore, pain is more than a signal for tissue damage. Timepoint: At the beginning of the study, before the exercises and at the end of the exercise period. Method of measurement: In this research, an analog visual scale is used to determine pain intensity. Functional Disability: The effects and consequences of chronic or acute conditions are said to affect various body systems and cause limitation or lack of people's ability to perform basic and functional activities, such as standing, sitting, dressing and walking in a natural range. Timepoint: At the beginning of the study, before the exercises and at the end of the exercise period. Method of measurement: In this research the Oswestry Questionnaire is used to evaluate the level of functional disability of the patients. The total score of the items of this scale is considered as the functional disability level of the people, which is zero without disability and 100 as maximum disability. This questionnaire has ten parts, each part has six sub-parts, which are graded from 0 to 5. The individual's disability score is calculated by multiplying the total points obtained by 2 and then dividing by 100 and is displayed as a percentage. Endurance: Muscle contraction and maintaining it for a predetermined period of time. Timepoint: At the beginning of the study, before the exercises and at the end of the exercise period. Method of measurement: Biofeedback will be used to measure the endurance of lumbar muscles. The duration of time when people maintain contraction with an intensity of more than sixty percent of the maximum power will be measured in seconds. Neuromuscular Coordination: It is an essential tool for the successful completion of a movement task, which is described in terms of accuracy and optimality. Timepoint: At the beginning of the study, before the exercises and at the end of the exercise period. Method of measurement: Biofeedback will be used to measure the Neuromuscular Coordination of muscles. Each person simulates the ramp pattern of Mehrsam Company's Motor Learning Biofeedback System 5 times. patient will rest 10 seconds between each attempt. In the end, the maximum muscle strength, the error criterion from the model, the similarity coefficient with the model, the error of the maximum increase and the error of the maximum decrease are measured by the software of this system. Patient Satisfaction with Physiotherapy Treatment: Patient Satisfaction is a complex and multidimensional concept. Patient satisfaction with physiotherapy has various aspects, which include the skill of the physiotherapist, the relationship between the physiotherapist and the patient, and the efficiency of the treatment. Measuring patients' satisfaction provides valuable information for physiotherapists to improve physiotherapy services to meet patients' needs. Timepoint: At the end of Treatment. Method of measurement: Patient Satisfaction with Physiotherapy Treatment will be measured by using MRPS Questionnaire (Persian Version). University of social welfare and rehabilitation sciences Approved 2022-11-23 Ethics Committee of University of Social Welfare and Rehabilitation Sciences kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)