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IRCT20200707048039N1 IRCT 2020-07-15 Tehran University of Medical Sciences Effect of adding back package to he primary care Adding back package to the primary care service, a cluster randomized field trial study 2020-09-22 anticipated 9440 Complete https://irct.ir/trial/49594 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to prevent statistical contamination between individuals, randomization will be done in the cluster form at the level of health bases. 16 health bases with equal coverage population will enter the block randomization process in Excel software and will be blocked in four groups of control, Exercise Intervention, Exercise Intervention + Risk Factor Training, and Exercise Intervention + Fear-avoidance Training. The randomization method is block randomization, the unit is cluster randomization, and non-stratified randomization is used to better represent the reality of our target community. In this study, Excel statistical software will be used for randomization. The sequence construction is in the form of 4 blocks, each of which includes all 4 types of intervention (control and intervention). Finally, for allocation concealment, the subjects and health care providers do not know which group they belong to, but they do know that there are four groups in this study, Blinding description: In this study, considering that each of the interventions is performed on separate bases, participants, health care providers (who are responsible for educating people and collecting data) were blinded to the type of low back pain package. The data analyst is also blinded to the type of training and back package. N/A Low back pain. Intervention 1: Control group: Without back package. Intervention 2: Intervention group 1: A group of simple specific aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people by a health care provider and pamphlet during a session and do not require special equipment. Intervention 3: Intervention group 2: A group of simple specific aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people by a health care provider and pamphlet during a session and do not require special equipment + Teaching tips about the risk factors for low back pain and how to maintain a proper physical position that is taught to people during a session by a health care provider and pamphlet. Intervention 4: Intervention group 3: A group of simple aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people during a session by a health care provider and pamphlets and do not require special equipment + educational tips on how to deal with fear and disability caused by low back pain that is taught to people during a session by a health care provider and pamphlet. Yes - There is a plan to make this available What will be shared: The incidence rate of low back pain, the prevalence of low back pain, the low back pain disability, the costs of treatments When: Starting in January 2025 for 5 years To whom: Researchers in the field of public health, sports medicine, and health policymakers Conditions: For systematic reviews and meta-analysis Where to obtain: Sports Medicine Research Center, Tehran University of Medical Sciences How to obtain: Request from the Corresponding author with a well-explained reason Comments:
public Mohammad Hossein Pourgharib Shahi
Jalal Al-Ahmad Highway, in front of Dr. Shariati Hospital, Sports Medicine Research Center
Tehran Iran (Islamic Republic of) 14395578 +98 21 8863 0227 pourgharib@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Hossein Pourgharib Shahi
Jalal Al-Ahmad Highway, in front of Dr. Shariati Hospital, Sports Medicine Research Center
Tehran Iran (Islamic Republic of) 14395578 +98 21 8863 0227 pourgharib@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) People affiliated with medical centers in rural areas People aged between 18 to 60 years old 18 years 60 years Both Diagnosed neoplasm Diagnosed significant psychiatric disorders Diagnosed Cognitive impairment Reluctance to participate M54.5 Low back pain N/A Prevention Prevention Prevention Control group: Without back package Intervention group 1: A group of simple specific aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people by a health care provider and pamphlet during a session and do not require special equipment Intervention group 2: A group of simple specific aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people by a health care provider and pamphlet during a session and do not require special equipment + Teaching tips about the risk factors for low back pain and how to maintain a proper physical position that is taught to people during a session by a health care provider and pamphlet Intervention group 3: A group of simple aerobic, strength and stretch exercises to strengthen the back muscles that are taught to people during a session by a health care provider and pamphlets and do not require special equipment + educational tips on how to deal with fear and disability caused by low back pain that is taught to people during a session by a health care provider and pamphlet Low back pain incidence. Timepoint: After 12 months. Method of measurement: Based on the recorded information from the patient's referrals to the doctor and recording the diagnosis of low back pain in the patient's electronic file. Disability. Timepoint: After 12 months. Method of measurement: Roland Morris Disability Questionnaire. Treatment costs. Timepoint: After 12 months. Method of measurement: Questionnaire. National Institute For Medical Research Development Approved 2019-06-16 National Institute for Medical Research Development No. 21, Besat St., West Fatemi St., Tehran, Iran National Institute for the Development of Medical Research (NIMAD) Tehran Tehran Iran (Islamic Republic of)