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IRCT20250604066066N1 IRCT 2025-11-22 Allameh Tabataba'i University, Tehran Comparison of the effects of combined exercises and DNS on pain, proprioception, balance, muscular endurance, and motor control ability in men with non-specific chronic low back pain NSCLBP Comparison of the effect of 8 weeks of combined exercises and DNS on pain, proprioception, balance, muscular endurance, and motor control ability in men with non-specific chronic low back pain: A randomized clinical trial 2025-10-21 anticipated 33 Complete https://irct.ir/trial/84241 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: For the random assignment of participants, a complete list of eligible individuals was first prepared. Then, a random sequence was generated using the 'Research Randomizer' website. This sequence included random assignments to the two study groups and was created without any researcher involvement. Based on this sequence, a sealed opaque envelope containing a slip with the assigned group was prepared for each participant number. Upon arrival of each participant, the envelope corresponding to their number was opened sequentially, in a way that could not be predicted by the staff. In this way, the allocation process was entirely random, concealed, and without any researcher interference, Blinding description: In this study, only the participants were blinded to group allocation. After randomization, each participant was placed in one of the three groups without knowledge of the type of intervention, and no explanation was given to them about the differences between the experimental and control groups. The intervention materials and instructions were presented in a way that participants could not clearly discern their group type. However, due to the nature of the study, the researchers and intervention administrators were aware of the group allocation. Therefore, the study is considered a 'single-blind' study, with only the participants being blinded. N/A Chronic nonspecific low back pain. Intervention 1: Intervention group1: Recipient of combined exercises. Intervention 2: Intervention group2: DNS exercises recipient. Intervention 3: Control group: They will not receive any protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations and adherence to participant confidentiality principles, individual participant data (IPD) from this study will not be publicly available. Additionally, according to institutional regulations and university policies, sharing raw data is not permitted. However, aggregated or analyzed data may be made available to qualified researchers upon formal request and following the necessary legal procedures.
public Shafe Abbasi
Faculty of Physical Education and Sport Sciences, Allameh Tabataba’i University, Between Aftab 2 Boulevard and Vafaei Boulevard, Ali Daei Boulevard, Sadra Town, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۸۹۶۸۴۵۱۱ +98 21 4839 4160 shafe.abbasi20@gmail.com The University of Allameh Tabatabaei scientific Shafe Abbasi
Faculty of Physical Education and Sport Sciences, Allameh Tabataba’i University, Between Aftab 2 Boulevard and Vafaei Boulevard, Ali Daei Boulevard, Sadra Town, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۸۹۶۸۴۵۱۱ +98 21 4839 4160 shafe.abbasi20@gmail.com The University of Allameh Tabatabaei Iran (Islamic Republic of) Men with chronic non-specific low back pain whose non-specific low back pain is diagnosed by a sports medicine specialist Willingness to participate in the study with written consent Participants should be between the ages of 18 and 65 At least 3 months of back pain experience No specific spinal pathology (such as disc herniation), no history of surgery or fracture, and able to perform daily activities without the need for assistive devices Having a score of 4 or higher on the pain questionnaire Lack of core stability and balance exercises for patients in the past 3 months Not engaging in professional exercise Individuals should have no exercise restrictions 18 years 65 years Male Withdrawal of consent to continue participation in the research Use of supportive tools such as a corset or brace Incidence of Back Pain with Non-Mechanical Origins and Causes Consumers of psychiatric or other neurological medications during the research History of surgery, acute spinal injuries, and congenital postural deformities Individuals who have diseases such as cancer, osteoporosis, arthritis, urinary tract infections, rheumatism, sciatica, pelvic diseases, inflammatory diseases, herniated discs, malignant tumors, nervous system diseases, progressive motor impairment, and spinal cord injuries M54.5 Low back pain Rehabilitation Rehabilitation N/A Intervention group1: Recipient of combined exercises Intervention group2: DNS exercises recipient Control group: They will not receive any protocol. Pain score in patients with chronic non-specific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: VAS questionnaire. Deep sensory score in patients with chronic nonspecific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Using a goniometer by the (Newcomer) method. Improving static balance in patients with chronic non-specific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Single-leg static balance test. Improving dynamic balance in patients with chronic nonspecific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Y balance test. Improving muscular endurance in patients with chronic nonspecific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Half sit-up test. Improving lumbopelvic movement control ability in individuals with chronic nonspecific low back pain. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Lumajoki motion control test. Allameh Tabataba'i University, Tehran Approved 2025-09-17 Ethics Committee in Research at Allameh Tabataba'i University Faculty of Physical Education and Sport Sciences, Pardis 2, Allameh Tabataba'i University, Opposite the West Gate of Azadi Stadium, Ali Daei Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)