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IRCT20260703070057N1 IRCT 2026-07-10 Buali Sina University Effect of physical exercises and mindfulness on chronic low back pain Effect of a multimodal intervention based on physical exercise, mindfulness, behavior change andeducation on pain, disability, kinesiophobia, movement patterns and trunk muscle endurance in employeeswith chronic non-specific low back pain 2026-07-23 anticipated 48 Recruiting https://irct.ir/trial/91420 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals were randomly assigned to the research groups. The randomization process was carried out using a Random Number Generator software. Specifically, a random number was generated for each participant, and based on the sequence of the generated numbers, the participants were assigned to the study groups, Blinding description: The evaluator responsible for recording and analyzing the data was not aware of the allocation of the participants to the experimental and control groups. N/A Condition 1: Chronic nonspecific low back pain (CNSLBP). Condition 2: Kinesiophobia (fear of movement). Condition 3: Altered lumbar movement patterns. Condition 4: Reduced trunk muscle endurance. Intervention group: The multimodal intervention consists of four main components delivered over eight weeks:Supervised physical exercise program: Sixteen sessions of 45 minutes each (two sessions per week) focusing on strengthening trunk core muscles. Each session includes 5 minutes of warm-up, 35 minutes of main strengthening exercises, and 5 minutes of cool-down with static stretching. Exercise intensity is regulated using the Rating of Perceived Exertion scale to avoid pain induction.Mindfulness-based stress reduction program: Eight weekly group sessions of 2.5 hours each using an adapted Mindfulness-Based Stress Reduction protocol by Kabat-Zinn. Sessions include practical exercises such as body scan, breathing meditation, gentle yoga, and compassion meditation, with daily home practice of 30 to 45 minutes.Continuous behavior change program: Use of free applications Google Fit, Samsung Health, or Apple Health to provide hourly inactivity alerts over 12 waking hours, prompting two minutes of light activity such as walking or stretching. Alerts are disabled during sleep and naps.Pain neuroscience education program: Five two-hour sessions every two weeks conducted by a specialized physiotherapist using slides, metaphors, images, and interactive discussions. Topics cover pain defense systems, neuroplasticity, maladaptive learning, and tools for reversing changes to enable sustainable pain self-management.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public MohammadAmin Dadgar
Hamadan, Modares Town, Abu taleb Street, Bu-Ali Sina University
Hamedan Iran (Islamic Republic of) 3869565178 +98 81 3838 1423 rohamdadgar7@gmail.com Bu-Ali Sina University. scientific MohammadAmin Dadgar
Hamadan, Shahrek-e Modares, Abu Talib Street, Bu-Ali Sina University
Hamedan Iran (Islamic Republic of) 3869565178 +98 81 3838 1423 rohamdadgar7@gmail.com Buali Sina university Iran (Islamic Republic of) Male employee. Diagnosed with non-specific chronic low back pain lasting more than 12 weeks. Provided written informed consent. Able to walk and move without external assistance. no limit no limit Male Presence of serious structural spinal disorders such as spondylolysis, spondylolisthesis, spinal canal stenosis, degenerative disc disease, herniated disc, tumor, trauma, fracture, cauda equina syndrome, or radicular pain. Acute or terminal illness. Recent physical injury. Severe physical or psychiatric illness preventing participation in the study. Medical prescription contraindicating participation in the intervention. Rehabilitation Intervention group: The multimodal intervention consists of four main components delivered over eight weeks:Supervised physical exercise program: Sixteen sessions of 45 minutes each (two sessions per week) focusing on strengthening trunk core muscles. Each session includes 5 minutes of warm-up, 35 minutes of main strengthening exercises, and 5 minutes of cool-down with static stretching. Exercise intensity is regulated using the Rating of Perceived Exertion scale to avoid pain induction.Mindfulness-based stress reduction program: Eight weekly group sessions of 2.5 hours each using an adapted Mindfulness-Based Stress Reduction protocol by Kabat-Zinn. Sessions include practical exercises such as body scan, breathing meditation, gentle yoga, and compassion meditation, with daily home practice of 30 to 45 minutes.Continuous behavior change program: Use of free applications Google Fit, Samsung Health, or Apple Health to provide hourly inactivity alerts over 12 waking hours, prompting two minutes of light activity such as walking or stretching. Alerts are disabled during sleep and naps.Pain neuroscience education program: Five two-hour sessions every two weeks conducted by a specialized physiotherapist using slides, metaphors, images, and interactive discussions. Topics cover pain defense systems, neuroplasticity, maladaptive learning, and tools for reversing changes to enable sustainable pain self-management. Primary outcome variable 1: Pain intensity measured by the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).Primary outcome variable 2: Degree of back disability assessed by the Oswestry Disability Index (ODI), scored from 0 to 100.Primary outcome variable 3: Health-related quality of life measured by the SF-36 questionnaire, covering physical and mental health domains.Primary outcome variable 4: Lumbar range of motion measured with a goniometer in flexion and extension directions.Primary outcome variable 5: Participants’ stress level assessed using the stress subscale of the DASS-21 questionnaire. Timepoint: Before the intervention begins (pre-test)Immediately after the 8-week intervention period (post-test)One-month follow-up after the intervention completion. Method of measurement: Pain intensity is measured using the Numerical Rating Scale, which ranges from zero (no pain) to ten (worst possible pain).Degree of back disability is assessed by the Oswestry Disability Index questionnaire, scored from zero to one hundred.Kinesiophobia is evaluated using the Tampa Scale of Kinesiophobia, which includes questions about fear of movement.Lumbar movement patterns are measured by the Lumbar Motor Control Test, assessing controlled movement performance.Trunk muscle endurance is assessed by the Biering-Sorensen Test, which records the time a specific position is maintained. Buali Sina University Approved 2026-04-25 Ethics committee of Buali sina university Hamedan, Modarres Town, Abutaleb Street, Bu-Ali Sina University Hamedan Hamadan Iran (Islamic Republic of)