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IRCT20230227057551N1 IRCT 2023-06-12 Kharazmi university The effect of motor control approach with and without whole body vibration on chronic non-specific low back pain The effect of motor control approach with and without whole body vibration on pain, postural stability, electrical activity and trunk muscle endurance of nurses with chronic non-specific low back pain 2023-06-22 anticipated 75 Complete https://irct.ir/trial/68854 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block randomization Randomization unit: it is individual. Randomization type: Block randomization will be done using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists. Patients who meet the inclusion criteria will be randomly assigned to two experimental groups (motor control exercises and combined motor control exercises with whole body vibration) and a control group, which will be determined at the beginning of the mentioned site on the size of the blocks. According to the sample size of this study (75 people), it is considered as blocks of 3, then the number of sets of random numbers that is needed is determined (three sets of 25 numbers are needed for each group), which these three sets include : 1. Experimental group A, 2. Experimental group B and C, control group). After clicking on the confirmation option in the opposite column, the randomization method will be determined based on the individual number, block size and group name from 1 to 25 for each group. For example, the first three players for three groups based on the block of three are as follows. • 1, 3, 1, Group A • 1, 3, 2, Group C • 1, 3, 3, Group B Concealment: Concealment of random allocation will be done using a random block table (25 blocks of 3) generated by the computer before the start of data collection by a researcher who will not be involved in calling or treating patients. Randomization tool: Random numerical sequence is placed in non-transparent and sealed envelopes. Another researcher, a researcher unaware of the initial steps, will open an envelope and proceed with the treatment as assigned by the group. N/A Chronic non-specific low back pain. Intervention 1: Intervention first group: they will participate individually and under full supervision for 12 sessions and each session lasts 30 minutes (including movement control exercises with a specific protocol that is adjusted based on the ability of the people). This protocol will be used under the supervision of a specialist doctor. The exercises will be done for 8 weeks (in the first 4 weeks as two sessions per week and in the second 4 weeks as one session per week). Intervention 2: The second intervention group: Individually and fully supervised for 12 sessions and each session for 45 minutes, first for 30 minutes movement control exercises and then for 15 minutes they will perform the whole body vibration movement protocol. The whole body vibration protocol includes 5 movements (dynamic squat with a cable: with a frequency of 5-6 Hz, squat with extension arms: with a frequency of 6-7 Hz, rising on the toes: with a frequency of 10 Hz, static squat: with a frequency of 8 up to 10 Hz and static squat by standing on the toe: with a frequency of 8 Hz) in two sets with 5 to 8 repetitions on the Wellengang oscillating plate, Mühlacker model, made in Germany with the specified frequency (5 to 8 10 Hz) is done. It should be noted that 30 seconds of active rest is included between each set (including three exercises of quiet standing, hip rotation and hanging with a cable). All exercises will be followed for 8 weeks (in the first 4 weeks as two sessions per week and in the second 4 weeks as one session per week). Intervention 3: Control group: Carrying out daily nursing activities and also not participating in sports activities such as going to the gym. Yes - There is a plan to make this available What will be shared: Some data, such as information on the main outcome, is shared after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: Scientific and cultural use for academics is allowed after the publication of the study Where to obtain: Applicants should know to send a message to the email listed in the study to receive the desired documents or data Karimiraziye39@gmail.com How to obtain: Finally, one week after sending the request to the e-mail karimiraziye39@gmail.com, I will respond to the requester to receive data/documents. Comments:
public Raziyeh Karimi
Unit 2, No. 8, Khordad Alley, 16 Meter North 1st St., Baath Blvd., Central Jannat Abad
Tehran Iran (Islamic Republic of) 1474877687 +98 21 4447 5025 karimiraziye39@gmail.com Kharazmi university scientific Raziyeh Karimi
Unit 2, No. 8, Khordad Alley, 16 Meter North 1st St., Baath Blvd., Central Jannat Abad
Tehran Iran (Islamic Republic of) 1474877687 +98 21 4447 5025 karimiraziye39@gmail.com Kharazmi University Iran (Islamic Republic of) Iran (Islamic Republic of) Female nurses in the age range of 30-40 years Female nurses with more than three years of work experience having lower back pain for more than three months (12 weeks) Getting a score between 3 and 7 from the Visual Analogue Scale questionnaire Not having any specific and regular sports activities Filling the informed consent form to participate in the study 30 years 40 years Female Having disorders of the nerve roots of the lumbar spine that have led to a decrease in the strength and reflexes of the lower limbs Having lesions such as fractures, cancer, inflammatory arthritis of the lumbar vertebrae and cauda equina and etc. Having a history of lumbar spine surgery Having cognitive disorders such as Alzheimer's, Parkinson's and dementia Having severe neuromuscular abnormalities Absence of confirmation from the clinical examining doctor in terms of the heart and lungs and the condition of the motor organs M54.5 Low back pain Treatment - Other Treatment - Other Lifestyle Intervention first group: they will participate individually and under full supervision for 12 sessions and each session lasts 30 minutes (including movement control exercises with a specific protocol that is adjusted based on the ability of the people). This protocol will be used under the supervision of a specialist doctor. The exercises will be done for 8 weeks (in the first 4 weeks as two sessions per week and in the second 4 weeks as one session per week). The second intervention group: Individually and fully supervised for 12 sessions and each session for 45 minutes, first for 30 minutes movement control exercises and then for 15 minutes they will perform the whole body vibration movement protocol. The whole body vibration protocol includes 5 movements (dynamic squat with a cable: with a frequency of 5-6 Hz, squat with extension arms: with a frequency of 6-7 Hz, rising on the toes: with a frequency of 10 Hz, static squat: with a frequency of 8 up to 10 Hz and static squat by standing on the toe: with a frequency of 8 Hz) in two sets with 5 to 8 repetitions on the Wellengang oscillating plate, Mühlacker model, made in Germany with the specified frequency (5 to 8 10 Hz) is done. It should be noted that 30 seconds of active rest is included between each set (including three exercises of quiet standing, hip rotation and hanging with a cable). All exercises will be followed for 8 weeks (in the first 4 weeks as two sessions per week and in the second 4 weeks as one session per week). Control group: Carrying out daily nursing activities and also not participating in sports activities such as going to the gym Intensity of pain. Timepoint: The measurement of pain intensity is done at the beginning of the study (before the start of the intervention) and 8 weeks later (after the end of the intervention period). Method of measurement: Visual analog scale questionnaire is used to measure pain intensity in eligible patients. The endurance (stability) of trunk muscles. Timepoint: The endurance of the trunk muscles is measured at the beginning of the study (before the start of the intervention) and 8 weeks later (after the end of the intervention period). Method of measurement: McGill functional tests are used to measure the stability of the extensor, flexor and lateral muscles of the trunk. Static and dynamic balance. Timepoint: The measurement of static and dynamic balance is done at the beginning of the study (before the start of the intervention) and 8 weeks later (after the end of the intervention period). Method of measurement: In order to evaluate static and dynamic balance, the Shirley, NY Biodex device, made in the USA, is used. This device has various tests to evaluate static and dynamic balance. Electrical activity of trunk muscles. Timepoint: The electrical activity of the trunk muscles is measured at the beginning of the study (before the start of the intervention) and 8 weeks later (after the end of the intervention period). Method of measurement: In this research, a surface electromyography device (Actos wireless model, made in Switzerland) with a frequency range of 1000 Hz is used. Kharazmi university Approved 2023-01-18 Research Ethics Committees of Sports Sciences Research Institute Jannat Abad Central Blvd., North 16 Meter St., Khordad Alley, No. 8, Unit 2 Tehran Tehran Iran (Islamic Republic of)