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IRCT20240311061249N1 IRCT 2024-03-30 Bu-Ali Sina University, Hamedan The Effect of Trunk Motor Control Exercises Along with Pain Neuroscience Education in Patients with Non-Specific Chronic Low Back Pain CNSLBP The Effect of Trunk Motor Control Exercises Along with Pain Neuroscience Education in Water and Land Environment on Disability, Psychological Variables and Postural Control of Patients with Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial 2024-01-20 anticipated 90 Complete https://irct.ir/trial/75915 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, Random Codes will be Generated Using Random Allocation Software and then they will be Placed Inside Sealed Envelopes. An Evaluator who is not Aware of the Study Purpose will Randomly Deliver the Envelopes to the Patients. As a Result, Patients will be Assigned to Experimental and Control Groups (30 People in Each Group) with a 1:1:1 Allocation. Patients and Assessors will be Unaware of Group Allocation, Blinding description: First, Random Codes will be Generated Using Random Allocation Software and then they will be Placed Inside Sealed Envelopes. An Evaluator who is not Aware of the Study Purpose will Randomly Deliver the Envelopes to the Patients. As a Result, Patients will be Assigned to Experimental and Control Groups (30 People in Each Group) with a 1:1:1 Allocation. Patients and Assessors will be Unaware of Group Allocation. 3 Chronic Non-Specific Low Back Pain. Intervention 1: Intervention Group: Motor Control Exercises in Four Weeks, 6 Sessions per Week (3 Sessions in the Swimming Pool of Bu-Ali Sina University and 3 Sessions in the Sports hall of Bu-Ali Sina University) Each Session will be done for 30 to 45 Minutes and the Neuroscience Education Includes 8 Topics Along with Verbal Explanations be Presented for 10 Minutes before the Beginning of the Treatment Sessions. Intervention 2: Intervention Group: Motor Control Exercises will be done in Eight Weeks, (4 Weeks in Water and 4 Weeks on Land) Three Sessions per Week for 30 to 45 Minutes Each Session and Neuroscience Education Includes 8 Topics with Oral Explanations for 10 It will be Provided Minutes Before the Start of Treatment Sessions. Intervention 3: Control Group: They will not Receive any Intervention. Yes - There is a plan to make this available What will be shared: All Data and Documents Can be Shared, but with the Non-Identification of People and the Preservation of Private Information of Subjects. When: The Results of this Study will be Available 3 Months after Publication in Journals. To whom: The Results of the Studies will be Accessible to all Members of the Society Without any Restrictions. Conditions: The Presented Documentation Can be Used for the Treatment of Non-Specific Chronic Low Back Pain. These Interventions are Applicable if they are Prescribed and Supervised by a Physiotherapist. Where to obtain: Fateme Soori's email Address is fatemesori1862@gmail.com How to obtain: When the Applicant Provides Documents for her Field of Work Related to the Subject of the Thesis and in Case of a Reasonable Request and a Commitment not to Misuse the Data of This Research, the Data will be Sent to her for 1 Working Week. Comments:
public Ali Yalfani
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
Hamedan Iran (Islamic Republic of) 6513861328 +98 81 3429 6149 fatemesori1862@gmail.com Bu-Ali Sina University, Hamedan scientific Ali Yalfani
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
Hamedan Iran (Islamic Republic of) 6513861328 +98 81 3429 6149 fatemesori1862@gmail.com Bu-Ali Sina University, Hamedan Iran (Islamic Republic of) Suffering from Chronic Low Back Pain for More than 3 Months The Cause of Low Back Pain is Unknown Age Range from 30 to 60 Years Pain Intensity more than 45 mm on the Visual Analog Scale Oswestrian Disability Index More than 25 30 years 60 years Female Pain in other Joints Misalignment of Upper and Lower Limbs History of Surgery Use of Painkillers in the Past 6 Months Physiotherapy in the Last Year Participate in Sports Sciatica Pain Spondylolysis Neuromuscular Disorders Neurological Disorder Respiratory Disorders Muscle Spasm Vertebral Fractures M54.5 Low Back Pain Rehabilitation Rehabilitation Diagnosis Intervention Group: Motor Control Exercises in Four Weeks, 6 Sessions per Week (3 Sessions in the Swimming Pool of Bu-Ali Sina University and 3 Sessions in the Sports hall of Bu-Ali Sina University) Each Session will be done for 30 to 45 Minutes and the Neuroscience Education Includes 8 Topics Along with Verbal Explanations be Presented for 10 Minutes before the Beginning of the Treatment Sessions Intervention Group: Motor Control Exercises will be done in Eight Weeks, (4 Weeks in Water and 4 Weeks on Land) Three Sessions per Week for 30 to 45 Minutes Each Session and Neuroscience Education Includes 8 Topics with Oral Explanations for 10 It will be Provided Minutes Before the Start of Treatment Sessions. Control Group: They will not Receive any Intervention. Pain, Fear of Movement, Stress, Anxiety, Depression, Pain Catastrophizing. Timepoint: In this Clinical Trial, the Researcher Intends to Evaluate the Variables of Pain, Fear of Movement, Stress, Anxiety, Depression, Pain Catastrophizing in Two time Periods Before the Intervention (Pre-Test) and After the Intervention (4 and 8 Weeks). Method of measurement: Pain (Visual Analog Scale), Fear of Movement (Tampa Questionnaire), Stress, Anxiety and Depression (Stress, Anxiety and Depression Questionnaire), Pain Catastrophizing (Pain Catastrophizing Questionnaire). Disability, Postural Control, Plantar Pressure Distribution, Vertical Ground Reaction Force. Timepoint: In this Clinical trial, the Researcher Intends to Evaluate Disability Variables, Posture Control, Plantar Pressure Distribution, Vertical Ground Reaction Force in two time Periods before the Intervention (Pre-Test) and after the Intervention (4 and 8 Weeks). Method of measurement: Disability (Oswestory Questionnaire), Posture Control, Plantar Pressure Distribution and Vertical Ground Reaction Force (Foot Pressure). There is no source of financial support. Approved 2024-03-09 کمیته اخلاق دانشگاه بوعلی سینا Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8 Hamedan Hamadan Iran (Islamic Republic of)