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IRCT20180429039470N2 IRCT 2023-08-21 Iran University of Medical Sciences Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain The effect of central stability exercises and cognitive tasks compared to general exercises and cognitive tasks on pain, disability and postural control of people with non-specific chronic low back pain. 2023-05-02 anticipated 34 Complete https://irct.ir/trial/71897 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done by the method of variable blocks, which will include four-letter blocks consisting of letters A and B. After that, according to the fact that 34 people are needed in the study and the blocks are four components, 9 random numbers will be prepared, which will determine the arrangement of the four component blocks. Then, the random treatment list will be placed in sealed and numbered envelopes in the form of letters A and B. Letter A will represent CSE exercises with cognitive task and letter B will represent GE exercises with cognitive task. Then, an envelope will be assigned to each patient in the order of entering the study and his group will be determined, Blinding description: In this study, due to the dissimilarity of the treatment and control groups, there is no possibility of blinding the participants and the therapist. Therefore, in the present study, only for objective evaluations, including assessment of postural stability and postural control strategies, the blinding of the evaluator will be done with respect to the grouping of the subjects under study. N/A Non-specific low back pain. Intervention 1: Intervention group: core stability exercises with cognitive tasks (16 sessions, three times a week of local muscle exercises). Intervention 2: Control group: general exercises with cognitive tasks (16 sessions, three times a week of global muscle exercises). Yes - There is a plan to make this available What will be shared: Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain When: Starting after publication To whom: This is only available for people working in academic institutions. Conditions: It can be used for advanced analysis and with new topics while maintaining ownership of university data. Where to obtain: Salehi.re@iums.ac.ir How to obtain: It will be done through the email registered in the protocol. Comments:
public Reza Salehi
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 Salehi.re@iums.ac.ir Iran University of Medical Sciences scientific Reza Salehi
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
Tehran Iran (Islamic Republic of) 15459-13478 +98 21 2222 2059 Salehi.re@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset. Pain score of 3 or more on a visual analog scale. Pain during quiet standing. Cognitive level above 24 based on mini-mental state examination (MMSE). 18 years 50 years Both Radicular pain and any neurological signs. Uncorrected vision impairment. Hearing problems. Vestibular dysfunctions. Cognitive deficit. Previous spinal surgery. Severe deformity or injury to the lower extremities. Rehabilitation Rehabilitation Intervention group: core stability exercises with cognitive tasks (16 sessions, three times a week of local muscle exercises) Control group: general exercises with cognitive tasks (16 sessions, three times a week of global muscle exercises) Pain intensity. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months ". Method of measurement: Visual analog scale. Disability level. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months ". Method of measurement: Oswestry disability index questionnaire. Center of pressure (COP) sway range for anteroposterior (AP range). Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. COP sway range for mediolateral (MA range). Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. COP sway velocity. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. Sway area. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. Short-term diffusion coefficient of stabilogram diffusion plot. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. Long-term diffusion coefficient of stabilogram diffusion plot. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. Critical point coordinates. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Force plate device. Quality of life. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: 12-item short form health survey. Kinesiophobia. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Tampa scale for kinesiophobia. Fear-avoidance beliefs. Timepoint: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ". Method of measurement: Fear-avoidance beliefs questionnaire. NCT05832918 Clinical trials.gov Iran University of Medical Sciences Approved 2023-01-21 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madad karan St., Shah Nazari St., Mader Square, Mirdamad Tehran Tehran Iran (Islamic Republic of)