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IRCT20251029067812N1 IRCT 2025-11-05 Babol University of Medical Sciences Effect of motor control exercises with and without McKenzie exercises on Kinesiophobia and pain self-efficacy in chronic low back pain Comparison of the effect of motor control exercises with and without McKenzie exercises on Kinesiophobia and pain self-efficacy in chronic low back pain patients 2025-11-22 anticipated 44 Complete https://irct.ir/trial/87148 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this parallel randomized controlled trial, since participants do not enter the study simultaneously and the investigators cannot predict which treatment group each patient will be assigned to, the block randomization method will be employed. In order to ensure an equal number of patients with different directional preferences (extension and lateral flexion, according to the McKenzie approach) in the two study groups, stratified sampling will be conducted using two strata. In this study, eligible participants who provide informed consent will be randomly assigned to either the intervention group or the control group in a 1:1 ratio, using a block randomization procedure (blocks of six) generated by the Random Allocation Software. The allocation process is designed to ensure that the investigators cannot predict the group assignment of the next participant. The randomization codes will be sequentially placed in opaque sealed envelopes, and as each new participant is enrolled, the clinic secretary will open the next envelope to determine the participant’s group assignment, Blinding description: This study is a single-blind trial. The outcome assessor, who is responsible for evaluating the study outcomes, will be blinded to the participants’ group allocation and will operate independently from the physiotherapist responsible for administering the interventions in each group. N/A Chronic low back pain. Intervention 1: The intervention group will receive ten sessions of electrotherapy combined with motor control exercises and McKenzie exercises. Intervention 2: The control group will receive ten sessions of electrotherapy combined with motor control exercises. Yes - There is a plan to make this available What will be shared: An Excel file containing data related to the primary and secondary outcomes will be shared. When: Access will be granted after the publication of the study results. To whom: The data will be available to researchers affiliated with academic and scientific institutions. Conditions: ChatGPT said: The Excel data file will be available solely for academic use upon request. Where to obtain: Via Email: t.seyedhoseinpoor@mubabol.ac.ir How to obtain: Request via email Comments:
public Tahere Seyedhoseinpoor
Babol University of Medical Sciences, Ganj Afrooz St, Kargar Sq, Babol, Mazandaran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 3219 4641 t.seyedhoseinpoor@mubabol.ac.ir Babol University of Medical Sciences scientific Tahere Seyedhoseinpoor
Babol University of Medical Sciences, Ganj Afrooz St, Kargar Sq, Babol, Mazandaran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 3219 4641 t.seyedhoseinpoor@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Patients aged between 20 and 50 years. Patients experiencing unilateral or bilateral pain extending from the T12 vertebra downward to the gluteal fold, with or without lower limb pain. Patients with chronic low back pain (lasting more than three months). Patients with chronic low back pain who, based on the McKenzie assessment, demonstrate a directional preference for extension or lateral movements Patients who score moderate to severe levels of kinesiophobia on the Fear-Avoidance Beliefs Questionnaire (score greater than 48). Patients reporting pain intensity greater than 3 20 years 50 years Both History of lumbar spine fracture or spinal surgery Presence of progressive malignant disease Cauda equina syndrome Cancer or other neoplastic conditions Spinal tumors Inflammatory or infectious diseases of the spine Pregnancy Spondylolisthesis Patients who have previously undergone McKenzie therapy Patients for whom no directional preference can be identified Patients with a sequestrated disc, confirmed by MRI In general, any individual with contraindications to exercise therapy or repetitive movements (with or without therapist-applied pressure) Lack of compliance in performing prescribed home exercises M54.5 Low back pain Rehabilitation Rehabilitation The intervention group will receive ten sessions of electrotherapy combined with motor control exercises and McKenzie exercises. The control group will receive ten sessions of electrotherapy combined with motor control exercises. Kineziophobia. Timepoint: Before Intervention and after completing 10 sessions of intervention. Method of measurement: Kineziophobia will be assessed using the persion version of the Fear-Avoidance Beliefs Questionnaire. Pain self-efficacy. Timepoint: Before Intervention and after completing 10 sessions of intervention. Method of measurement: Pain self-efficacy will be measured using the Persian version of Pain Self-Efficacy Scale. Pain intensity. Timepoint: Before intervention and after completing 10 sessions of intervention. Method of measurement: Pain intensity will be measured using the Visual Analogue Scale. Functional disability. Timepoint: Before intervention and after completing 10 sessions of intervention. Method of measurement: The level of functional disability will be assessed using the Persian version of the Roland-Morris Disability Questionnaire. Babol University of Medical Sciences Approved 2025-10-13 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz St, Kargar Sq, Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)