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IRCT20210701051754N1 IRCT 2021-07-07 Kharazmi University Effect of Pilates with pain education in improvement of knee osteoarthritis Evaluation of adding Pain neuroscience education to Pilates exercises on reducing on pain and improving function and psychological variables in individuals with knee osteoarthritis 2021-07-11 anticipated 44 Complete https://irct.ir/trial/57239 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following the baseline examination, by using the method shown on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants will be randomly assigned into the pain neuroscience education plus Pilates exercises group and Pilates exercises group. Simple randomization will be used. Concealed allocation is performed using a computer-generated block randomized table of numbers (1 for pain neuroscience education plus Pilates exercises group and 2 for Pilates exercises group) created before the start of data collection by a researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelopes. Another researcher, blind to the baseline examination, open an envelope and process with treatment according to the group assignment. An independent assessor who is not known about the study’s hypothesis and methods and is blind to the treatment group, assess the outcome measures before the interventions, and 8 weeks after interventions, Blinding description: In this study, the outcome assessor was blinded of the process of randomization and division of individuals into two experimental and control groups. N/A Knee osteoarthritis. Intervention 1: Intervention group: Individuals in this group receive 3 sessions of pain neuroscience education and 24 session (for 8 weeks) Pilates exercises. Education includes 3 individualized sessions (30 and 60 minutes) held by a physical therapist. It reframes the patient's negative beliefs about pain by providing information about the nature of pain. This approach can reduce fear avoidance and avoidance behavior, and increase self-efficacy. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis. Intervention 2: Control group: This group only receive Pilates exercises. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis. https://doi.org/10.1186/s13075-023-03079-7 Results Significant within-group differences were observed in all outcomes in both groups at post-treatment. There were no statistically between-group differences in pain (adjusted mean difference: -0.8; 95% CI -2.2 to 0.7; p = 0.288), physical limitation (adjusted mean difference: -0.4; 95% CI -4 to 3.1; p = 0.812) and function (adjusted mean difference: -0.8; 95% CI -1.8 to 0.1; p = 0.069) at eight weeks. For pain catastrophizing (adjusted mean difference: -3.9; 95% CI -7.2 to -0.6; p = 0.021), kinesiophobia (adjusted mean difference: -4.2; 95% CI -8.1 to -0.4; p = 0.032), and self-efficacy (adjusted mean difference: 6.1; 95% CI 0.7 to 11.5; p = 0.028) statistically between-group improvements were observed favoring PNE followed by PEs group after the treatment. Yes - There is a plan to make this available What will be shared: Only demographic and outcomes-related data will be shared. When: After publishing paper(s) extracted from the study. To whom: The data can be displayed and shared at the reasonable request of the Iranian Clinical Trial Registration Center, journals, and university individuals /researchers who are conducting research and scientific activities in this field. Conditions: Data analysis and the use of documentation can only be done provided that their results are reported in systematic review articles by academic researchers and authors. Requirements for sharing data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the study researchers/authors 2. A brief and logical explanation of how to use the data or documentation 3. Ensuring that the protocol for systematic review studies, requesting access to data or documentation, is recorded. Where to obtain: Through asking from Authors Pouya Rabiei Pouya.rabiei.pr@gmail.com Amir Letafatkar letafatkaramir@yahoo.com Bahram Sheikhi sheikhibahram@gmail.com How to obtain: The applicant can request details from the researchers within 7 to 10 days using the message sent by email. Comments:
public Amir Letafatkar
Center for Human Movement Sciences Kharazmi University Mirdamad, Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
Tehran Iran (Islamic Republic of) 15719-14911 +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi University scientific Amir Letafatkar
Center for Human Movement Sciences Kharazmi University Mirdamad, Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
Tehran Iran (Islamic Republic of) 15719-14911 +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi University Iran (Islamic Republic of) Being Persian-native speaker male and female Being above 45 years old Having primary complaint of knee pain diagnosed as knee OA (>3 months’ duration) by an orthopedic physician. 45 years no limit Both Having self-reported knee replacement or any other lower limb surgery 6 months prior to participation, Having a history of inflammatory, metabolic or neurological disease, Having knee ligament or meniscus injury in previous year, Having any mental health conditions Using therapeutic modalities 6 months before participation. M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: Individuals in this group receive 3 sessions of pain neuroscience education and 24 session (for 8 weeks) Pilates exercises. Education includes 3 individualized sessions (30 and 60 minutes) held by a physical therapist. It reframes the patient's negative beliefs about pain by providing information about the nature of pain. This approach can reduce fear avoidance and avoidance behavior, and increase self-efficacy. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis. Control group: This group only receive Pilates exercises. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis. Pain intensity. Timepoint: Before the intervention and after 8 weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis (WOMAC) Index. Function. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Timed “Up & Go” (TUG) test. Pain Catastrophizing. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Pain Catastrophizing Scale (PCS). Kinesiophobia. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Tampa Scale for Kinesiophobia (TSK). Self-efficacy. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Pain Self-Efficacy Questionnaire (PSEQ). Physical activity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis (WOMAC) Index. This study has been conducted by the researchers and no organizational fund has been received Approved 2021-05-19 Sport Sciences Research Institute No. 3, Fifth Alley, Mir Emad St., Ostad Motahari St., Tehran Tehran Tehran Iran (Islamic Republic of)