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IRCT20191218045786N1 IRCT 2021-03-02 University of Lahore , Main Campus Stabilization Exercises for elderly patients with back pain The effects of stabilization exercises in addition to routine physical therapy in elderly patients with back pain; A randomized controlled trial 2021-01-29 anticipated 72 Complete https://irct.ir/trial/44507 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Patients, once accepted into the study will be randomly assigned to a treatment group by Chit-box method, either experimental group (stabilization exercises and routine Physical therapy or control group (routine physical therapy and stretching exercises). There will be added co-intervention and home program for both groups. This will be parallel group randomized controlled trial with 1:1 allocation ratio into two groups. Each patient therefore will have an equal chance of being selected in either group. For random allocation of at least 60 cases into two groups equally, prepare 60 chits writing “C” (for Control group) on 30 chits and “E” (for Experimental group) on 30 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. . The first case registered will go to the control group, second group to the experimental group and the sequence will be continued till the selection of the last participant. The treatment procedures will be repeated for 5 sessions of 45 minutes each per week for 4 weeks (20 sessions).The Post-test scores of Visual analogue scale (VAS), berg balance scale (BBS), trunk muscles endurance tests, trunk range of motion (ROM) and functional disability will be collected after one month of treatment administration. The patients will have to read the letter of information and if they agree to participate then they will be asked to sign the letter of consent before they are allowed to participate in the study. All the patients can contact to the researcher in order to find out any further information regarding their participation in the study. The participants will be provided the facility as per required for the research. The health of the patients will be on priority and all the patients will be free to withdrawn anytime, Randomization description: A single bind randomized controlled design will be used.Assessor will be blinded in the present study.Patients, once accepted into the study will be randomly assigned to a treatment group by Chit-box method, either experimental group (stabilization exercises and routine Physical therapy or control group (routine physical therapy and stretching exercises). There will be added co-intervention and home program for both groups. This will be parallel group randomized controlled trial with 1:1 allocation ratio into two groups. Each patient therefore will have an equal chance of being selected in either group. The patients will be allocated into two groups i.e. Experimental group and control group by randomization through Chit-box method. Experimental group patients will be treated with stabilization exercises and routine physical therapy while those of control group will be treated with routine physical therapy and stretching exercises. Chit-Box Method: For random allocation at least 60 cases into two groups equally, prepare 60 chits writing “C” (for Control group) on 30 chits and “E” (for Experimental group) on 30 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. According to the sequence the first case registered will go to the control group, second case to the experimental group and will continue the sequence till last participant selection, Blinding description: This will be a single blinded randomized controlled trial .The assessor will only be kept blinded in this research study. The relevant details of the research study will be given to the participants at the time of taking consent; however they will remain unaware of their own group allocation. The assessor will remain unaware about who will be selected as research sample participants including unaware about experimental and control groups. The physical therapist will not be allowed to take the pre-post score outcome measurements. The assessors will not know the details of the treatment. The principal investigator alone will administer the treatment. Final session outcome measurements (post intervention) will be recorded by the above mentioned assessor. 4 Chronic Back pain. Intervention 1: Experimental Group: The participants of the experimental group will perform routine Physiotherapy exercise plus specific Stabilization exercises of the back. The duration of the exercises will be 45 minutes.There will be total 20 sessions( 4 weeks ), including 5 sessions/ week. Intervention 2: Control group: The participants of the Control group will perform routine Physiotherapy exercise plus stretching exercises of the back. The duration of the exercises will be 45 minutes. There will be total 20 sessions( 4 weeks ), including 5 sessions/ week. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Data will be available to the other people after the completion of the study and will remained available till 6 months To whom: Data will be available for the people working in academic institutions Conditions: Data will be shared for the purpose of RCT and other interventional research studies. Data can be accessed by communicating with principle invigilator" Muhammad Shahid" through email address: Shahidmirkhan@yahoo.com Where to obtain: Data is available by communicating with principle invigilator" Muhammad Shahid" through email address: Shahidmirkhan@yahoo.com How to obtain: Data/document can be accessed by communicating with principle invigilator" Muhammad Shahid" through email address: Shahidmirkhan@yahoo.com Comments: N/A
public Dr. Muhammad Shahid
University of Lahore, Main Campus, Lahore 1-KM Defence Road.off bhopatian Chowk, Lahore
Lahore Pakistan 54000 +92 42 99200600 Shahidmirkhan@yahoo.com University of Lahore scientific Dr. Muhammad Shahid
University of Lahore, Main Campus 1-KM Defence Road.off bhopatian Chowk, Lahore
Lahore Pakistan 54000 +92 42 99200600 Shahidmirkhan@yahoo.com University of Lahore, Main Campus Pakistan Age group 60 years and above Both male and female patients Elderly with chronic backache(more than 3 months) Independent gait ability with or without walking aid for a minimum of 15 m. Adequate vision and hearing for completion of the study protocol, as indicated by the ability to follow written and oral instructions during screening Capacity to understand and follow instructions Elderly with adequate stamina to perform stabilization 60 years no limit Both A history of stroke or other neurologic diseases or disorders Subjects with specific pathology, such as systemic inflammatory diseases (e.g. systemic lupus erythematous(SLE), rheumatoid arthritis(RA), nephritis etc.), prolapsed disc(PD), fractures and deformities (spine or extremities), bone tumors and bone infections Pain, limited motion, or weakness in the lower extremity that affects performance of daily activities (by self-report) Vestibular dysfunctions e.g. Benign Paroxysmal Positional Vertigo (BPPV) Acute cardiac surgeries e.g. Coronary artery bypass grafting (CABG`s ) Unstable angina e.g. Myocardial infarction (MI) Persistent pulmonary pathology( e.g. exertional dyspnoea (ED) M54.5 Low back pain Rehabilitation Rehabilitation Experimental Group: The participants of the experimental group will perform routine Physiotherapy exercise plus specific Stabilization exercises of the back. The duration of the exercises will be 45 minutes.There will be total 20 sessions( 4 weeks ), including 5 sessions/ week. Control group: The participants of the Control group will perform routine Physiotherapy exercise plus stretching exercises of the back. The duration of the exercises will be 45 minutes. There will be total 20 sessions( 4 weeks ), including 5 sessions/ week Back Pain. Timepoint: Before intervention and at 4 weeks after intervention. Method of measurement: Scoring by VAS ( Visual Analigue Scale ). ROM (Range of Motion). Timepoint: Before intervention and at 4 weeks after intervention. Method of measurement: Scoring , Degree measurement by Goniometer. Endurance of Trunk Flexors and Extensors. Timepoint: Before intervention and at 4 weeks after intervention. Method of measurement: Scoring by Endurance Tests. Balance. Timepoint: Before intervention and at 4 weeks after intervention. Method of measurement: Berg Balance Scale. Functional Disability. Timepoint: Before intervention and at 4 weeks after intervention. Method of measurement: Oswestry Disability Index. University of Lahore , Main Campus Approved 2018-09-20 Instituitional Review Board ( IRB), University of Lahore, Lahore, Pakistan 1-KM Defence Road.off bhopatian Chowk, Lahore Lahore Punjab Pakistan