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IRCT20191027045257N3 IRCT 2023-04-09 Tehran University of Medical Sciences Investigation effect of Lumbar-sacral recovery machine on sign and symptom of patients with discopathy Investigation effect of Lumbar-sacral recovery machine on severity of sign and symptom of patients with discopathy 2023-03-16 anticipated 74 Complete https://irct.ir/trial/69067 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Random allocation of samples will be done at the individual level through sealed envelopes from among those who refer to the research environments (Clinics of Sina and Imam hospitals). The randomization method will be simple. The random allocation of samples will be in such a way that sealed envelopes will be prepared according to the number of samples (37 envelopes for the control group and 37 for the intervention group). Patients referring to the mentioned clinics who meet the entry criteria are asked to choose one item from among 74 envelopes to determine their group, Blinding description: Blinding will be for the statistical analyzer so that the data will be entered into spss software by the other person and the experimental and control groups will be marked with numbers 1 and 2, then the statistical analyzer will perform the relevant tests on the data. 3 Discopathy. Intervention 1: Intervention group: The intended intervention is the use of a back and knee recovery device (Kemarasa). The intervention method is that the person is slowly placed on the device in a chair position and after the initial settings such as sitting height and other controllable items, the person slowly turns from the chair position into a bed position and after fixing the upper body and For the lower body, a different recovery program is implemented that includes various types of stretching. The tension applied to the vertebral column in terms of the type of design and the degree of freedom of the tension angle reduces the injury to a minimum, even for high-risk people. The number of intervention sessions three times a week is between 30 and 35 sessions, and this number of sessions varies depending on individual differences and structures, including lifestyle, mental and psychological state, physical and stress. The intervention is performed by a trained technician. Intervention 2: Control group: In the control group, the demographic information form and visual scale of pain intensity and comfort and katz-ADL activities of daily living will be completed at the beginning of the study and also at the end of the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is The publication of the article and the final report of the plan will be done. There is no further information
public Masoumeh Zakerimoghadam
Tohid square, Mirkhani street
Tehran Iran (Islamic Republic of) 6579867 +98 21 6105 4315 zakerimo@gmail.com Tehran University of Medical Sciences scientific Masoumeh Zakerimoghadam
Tohid square- Mirkhani street- Nursing Faculty
Tehran Iran (Islamic Republic of) 878768 +98 21 6105 4315 zakerimo@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 60 years old Having the desire to use the back and knee recovery device along with other prescription treatments of your doctor Diagnosis of lumbar discopathy and sacral grade 1 and 2 to the diagnosis of the doctor 18 years 60 years Both Existing other disease or abnormalities in the spine M51.9 Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder Rehabilitation N/A Intervention group: The intended intervention is the use of a back and knee recovery device (Kemarasa). The intervention method is that the person is slowly placed on the device in a chair position and after the initial settings such as sitting height and other controllable items, the person slowly turns from the chair position into a bed position and after fixing the upper body and For the lower body, a different recovery program is implemented that includes various types of stretching. The tension applied to the vertebral column in terms of the type of design and the degree of freedom of the tension angle reduces the injury to a minimum, even for high-risk people. The number of intervention sessions three times a week is between 30 and 35 sessions, and this number of sessions varies depending on individual differences and structures, including lifestyle, mental and psychological state, physical and stress. The intervention is performed by a trained technician. Control group: In the control group, the demographic information form and visual scale of pain intensity and comfort and katz-ADL activities of daily living will be completed at the beginning of the study and also at the end of the study. Pain. Timepoint: Before intervention and at the end session of intervention. Method of measurement: Visual Analogue scale (VAS). Activity Daily Living. Timepoint: Before intervention and at the end session of intervention. Method of measurement: Katz- Activity Daily Living. Tehran University of Medical Sciences Approved 2023-02-18 Ethics committee of Tehran University of Medical Sciences Tohid square- Nursing & Midwifery faculty Tehran Tehran Iran (Islamic Republic of)