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IRCT20220911055941N1 IRCT 2023-07-22 Iranian academic center for education culture and research Investigation of manual therapy and strengthening of the back and hip joints in elderly people suffering from chronic back and hip pain Comparison of the effect and durability of corrective exercises and manual therapy focused on the back and hip on disability, function, pressure pain, pain map, health and psychological status of the elderly with chronic back and hip pain 2023-07-18 anticipated 75 Complete https://irct.ir/trial/66281 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random permuted blocks randomization (16 blocks with size 8), four treatment combinations are independently allocated to participants by1:1:1 ratio (after the initial assessment). The random sequence list was generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983), and using (https://www.randomizer.org) This step will be guaranteed by a blind assessor, Blinding description: The assessor will be blind to group allocation. Participants will not be blind to the study and grouping; however, they were not aware which treatment will be considered as therapeutic (There is an unavoidable risk of bias in this study where the intervention cannot be blinded to interventionists, patients). Before the evaluation, the necessary training will be given to the outcome assessor in relation to how to measure the outcomes in order to prevent any questions and answers between the assessor and the participants. 2 Hip disorders (osteoarthritis) and back pain. Intervention 1: Intervention group: Thigh-focused exercises are divided into two on-site training sessions and two home training sessions for eight weeks, and the participants undergo functional exercises and manual therapy of both thighs for 45 minutes, and home exercises to be performed daily Exercises that do not include hip stretching, hip strengthening, and trunk muscle exercises are performed for 15 minutes. Intervention 2: Intervention group: The exercises focused on the spine were also divided into two sessions of on-site training and two sessions of training at home for eight weeks, where the on-site training includes functional exercises, manual treatment of the lumbar spine, and a stationary bike without resistance for 45 minutes, and the training At home, back flexibility exercises are done for 15 minutes. Intervention 3: Intervention group: Spinal and hip focused exercises include both previous exercise protocols, two sessions per week for eight weeks of 90-minute on-site training and 30-minute home training. Yes - There is a plan to make this available What will be shared: Only part of the data, such as the dependent variables and the mean of all samples, can be shared in scientific papers. When: The access period starts 6 months after the results are published To whom: Personal information is confidential and general results are available to everyone in the article Conditions: The information is not available to anyone. General results are available to all in the article. Where to obtain: Mobina Khabiri 0098 9157709654. Email: mobinakhabiri@khu.ac.ir How to obtain: 6 months after printing the results, the applicant can have the data by sending an email. Comments:
public MobinaKhabiri
Kharazmi Human Movement Science Center, Mirdamad University, South Rozen St., Hessari St., Country Sports Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 mobinakhabiri@khu.ac.ir Iranian academic center for education culture and research scientific MobinaKhabiri
Khwarazmi Human Movement Science Center, Mirdamad University, South Rozen St., Hessari St., Country Sports Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 mobinakhabiri@khu.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Low back pain > 3months for at least ½ of the days in the last 6months Moderate low back pain intensity (>3 on a scale of 0-10) Normalized isometric hip internal rotation strength <0.26 Hip Disability and Osteoarthritis Outcome Score >5 on pain relateditems P4-P8 60 years 85 years Both Previous hip fracture with repair Hip fracture within the last 15 years without repair Known spinal pathology other than spinal stenosis and/or osteoarthritis Severely impaired mobility (ie, requires the use of a wheelchair) Folstein Mini-Mental State Examination Score <24 Severe visual or hearing impairment Red flags such as fever, significant unintentional weight loss > 10 pounds pain that awakens or keeps one awake at night trauma that preceded the onset of pain signs and symptoms of cauda equina Significant pain in the legs greater than the back Acute illness (eg, COVID-19) Receipt of manual or exercise therapy for low back or hip within thelast 3 months N8103. M54 Hip ImpairmentsLow back pain Rehabilitation Rehabilitation Rehabilitation Intervention group: Thigh-focused exercises are divided into two on-site training sessions and two home training sessions for eight weeks, and the participants undergo functional exercises and manual therapy of both thighs for 45 minutes, and home exercises to be performed daily Exercises that do not include hip stretching, hip strengthening, and trunk muscle exercises are performed for 15 minutes. Intervention group: The exercises focused on the spine were also divided into two sessions of on-site training and two sessions of training at home for eight weeks, where the on-site training includes functional exercises, manual treatment of the lumbar spine, and a stationary bike without resistance for 45 minutes, and the training At home, back flexibility exercises are done for 15 minutes Intervention group: Spinal and hip focused exercises include both previous exercise protocols, two sessions per week for eight weeks of 90-minute on-site training and 30-minute home training. Disability. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: The way of measuring back disability by the Quebec Back Pain Disability Scale and hip disability through the Osteoarthritis Outcome Score questionnaire will be investigated. Function. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: The 30-second chair test, the geriatric physical fitness exam, and the walking speed test will be used to assess performance. Pressure pain. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: The pressure will be measured using a manual pressure gauge with a stimulation surface of one square centimeter. Then the pain level is done by visual analog scale. Pain map. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: In this research, the lumbar region will be measured at 27 points by an ergometer. Health. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: A self-confidence test will be used to assess health status. Psychological status. Timepoint: Before intervention, after 8 weeks of intervention, and after 6 months of follow-up. Method of measurement: The psychological variable will be assessed using the health questionnaire, the self-efficacy for exercise, the modified scale of walking efficiency, and the short scale of falling efficiency. kharazmi University Approved 2022-07-20 کمیته اخلاق پژوهشگاه تربیت بدنی و علوم ورزشی Number 3,Fifth Alley, Mir Emad Street, Ostad Motahari Street, Tehran Street, Tehran City Tehran Tehran Iran (Islamic Republic of)