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IRCT20200315046784N1 IRCT 2021-10-06 Iran University of Medical Sciences Effectiveness of knee external support (knee orthosis and or kinesiotape) on knee osteoarthritis The effectiveness of knee orthosis versus Kinesio tape on pain, physical function, strength and proprioception in patients with knee osteoarthritis 2021-10-13 anticipated 56 Complete https://irct.ir/trial/59032 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 50, however, to take account of potential withdrawals, 56 patients (n=28 per group) will be recruited for the study. First, create and seal 28 treatment A envelopes and 28 treatment B envelopes. To create a block of 4, we will select 2 treatment A envelopes and 2 treatment B envelopes. We will shuffle these 4 envelopes thoroughly, and place this block of 4 in a separate pile. Then, we will prepare additional blocks of 4 until all 28 treatment A and B envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 14 individual piles of shuffled blocks of 4, for example AABB, BBAA, ABBA, BAAB, ABAB, BABA, Blinding description: The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and or tape, and the patients will remove their knee orthosis or kinesio-taping before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician. N/A knee osteoarthritis. Intervention 1: Intervention group: knee orthosis: Knee orthosis is made from an elastic/neoprene material and have lateral stays for more support. The patients will be asked to wear the knee orthosis all day long for 4 weeks. Intervention 2: Intervention group: kinesiotape: three ‘‘I’’ strips will be taken and applied with a 50% to 75% tension. The base of the first strip will be applied 10 cm below the anterior superior iliac spine, and will be pulled along the course of the rectus femoris until the superior border of the patella. The base of the second ‘‘I’’ strip will be applied below the greater trochanter and the tape will be pulled along the course of the vastus lateralis until the lateral border of the patella. The base of the third strip will be applied from the middle 1/3 of the medial aspect of the thigh. The tape will be pulled along the course of vastus medialis towards the medial border of the patella. Kinesio tape will be applied once a week for 4 weeks, with 2 day off for the skin rest between applications. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences scientific Fatemeh Azadinia
Shahnazari st., Mother sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) pain intensity of at least 4 Kellgren and Lawrence grade 2 or 3 the American College of Rheumatology classification criteria standing and walking without assistance age ranging from 50 to 65 years 50 years 65 years Both knee flexion contracture corticosteroid injection within the past 6 month neurological diseases systemic diseases BMI of more than 36 diabetes mellitus history of wearing knee orthoses or applying Kinesio-tape for the last 6 months Patellofemoral pain syndrome Hip and knee replacement M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Intervention group: knee orthosis: Knee orthosis is made from an elastic/neoprene material and have lateral stays for more support. The patients will be asked to wear the knee orthosis all day long for 4 weeks. Intervention group: kinesiotape: three ‘‘I’’ strips will be taken and applied with a 50% to 75% tension. The base of the first strip will be applied 10 cm below the anterior superior iliac spine, and will be pulled along the course of the rectus femoris until the superior border of the patella. The base of the second ‘‘I’’ strip will be applied below the greater trochanter and the tape will be pulled along the course of the vastus lateralis until the lateral border of the patella. The base of the third strip will be applied from the middle 1/3 of the medial aspect of the thigh. The tape will be pulled along the course of vastus medialis towards the medial border of the patella. Kinesio tape will be applied once a week for 4 weeks, with 2 day off for the skin rest between applications. Pain. Timepoint: pre-intervention, and after 4-weeks intervention. Method of measurement: Visual Analogue Scale (VAS). WOMAC index. Timepoint: pre-intervention, and after 4-weeks intervention. Method of measurement: overall WOMAC score. Position sense error. Timepoint: Pre-intervention, and after 4 weeks intervention. Method of measurement: Isokinetic Machine. Threshold to detection of passive motion. Timepoint: pre-intervention, after 4-weeks intervention. Method of measurement: Isokinetic Machine. Force sense. Timepoint: Pre-intervention, and after 4-weeks intervention. Method of measurement: Isokinetic Machine. Quadriceps strength. Timepoint: Pre-intervention, and after 4-weeks intervention. Method of measurement: Isokinetic machine. Timed Up and Go. Timepoint: Pre-intervention and after 4-weeks intervention. Method of measurement: time via chronometer. One leg stance. Timepoint: pre-intervention, and after 4-weeks intervention. Method of measurement: time via chronometer. Balance index. Timepoint: pre-intervention, and after 4-weeks intervention. Method of measurement: Biodex Balance system. Iran University of Medical Sciences Approved 2021-01-31 Ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)