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IRCT20210701051754N2 IRCT 2021-08-21 Kharazmi University Effect of education on improving patellofemoral pain Investigating the effect of stabilization exercises with and without education on pain, function, and psychological factors in individuals with patellofemoral pain 2021-07-23 anticipated 50 Complete https://irct.ir/trial/57362 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following the baseline examination, by using the method on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants are randomly assigned into the experimental group (education plus stabilization exercises) and control group (stabilization exercises). This method was used based on similar previous study. On this website, we will enter the number of sets you want (two sets of numbers are required; 1. Experimental group and 2. Control group). The numbers that Research Randomizer needs to generate in each set will be specified (two sets of 30 numbers are required for each group). The lowest and highest value of the numbers that need will specify (range of 1 up to 60). Concealed allocation is performed using a computer-generated block randomized table of numbers (4 Blocks, 2 allocations for experimental group and 2 allocations for control 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, opens an envelope and processed with treatment according to the group assignment. A blinded outcome assessor who does not know the hypothesis and study methods, measures outcome at baseline, 8 weeks post-intervention, and 3 months follow-up, Blinding description: In this study, the outcome assessor was blind to the process of randomization and assignment of individuals into experimental and control groups. N/A patellofemoral pain. Intervention 1: Intervention group: Patient in this group receive 2 supervised sessions for education before stabilization exercises. Each session is provided one-by-one between a patient and allocated physical therapist and lasts approximately between 30 and 45 minutes for each patient. As kinesiophobia and pain catastrophizing are important in patellofemoral pain, each session aims to provide information about the nature of pain to reduce kinesiophobia and avoidance behavior, and consequently to promote self-efficacy. Using explanation and showing pictures, the discussed subjects in each session included: (1) the cause and the reasons behind PFP happening (e.g., main passive and active structures of the knee joint, important roles of the hip joint alignment and musculature); (2) the ways to manage pain (e.g., how to move better during daily activities, preventing knee malalignment [knee valgus] during standing, walking, taking stairs, from sitting to standing, and other activities). For stabilization exercises, exercises are designed for 8 weeks, 3 sessions for each week, and 45 to 60 minutes for each session (the initial 10 minutes for warm-up, and the final 10 minutes for cooldown). Eight weeks of exercise are divided into 3 parts with specific aims. In the first 2 weeks (1st part) the emphasis is on improving motor control of the trunk and hip muscles. In the following 3 weeks (2nd part) the aim is to increase the strength of the trunk and hip muscles and to continue improving motor control using weight-bearing activities. In the last 3 weeks (3rd part) the load is increased, and the exercises became more difficult. Intervention 2: Control group: This group receives only stabilization exercises. exercises are designed for 8 weeks, 3 sessions for each week, and 45 to 60 minutes for each session (the initial 10 minutes for warm-up, and the final 10 minutes for cooldown). Eight weeks of exercise are divided into 3 parts with specific aims. In the first 2 weeks (1st part) the emphasis is on improving motor control of the trunk and hip muscles. In the following 3 weeks (2nd part) the aim is to increase the strength of the trunk and hip muscles and to continue improving motor control using weight-bearing activities. In the last 3 weeks (3rd part) the load is increased, and the exercises became more difficult. https://doi.org/10.1016/j.apmr.2023.08.030 Abstract Objective: To investigate the effect of adding education to trunk and hip exercises in patients with patellofemoral pain (PFP). Design: A randomised controlled trial. Setting: Research laboratory. Participants: Sixty patients with PFP were randomly assigned to either an experimental group (education followed by trunk and hip exercises, n= 30) or a control group (trunk and hip exercises, n= 30). Interventions: Both groups received 8 weeks of trunk and hip exercises, while patients in the experimental group participated in 3 prior education sessions. Main Outcome Measures: The primary outcome was pain; secondary outcomes were pain catastrophizing, kinesiophobia, function, and muscle strength. Outcomes were assessed at baseline, after 8 weeks (post-intervention), and 3 months post-intervention (follow-up). Results: No significant between-group differences were observed for pain outcome post-intervention. The experimental group showed superiority over the control group in the improvement of pain catastrophizing (mean difference: -2.32; 95% confidence interval [CI] -1.059 to 0.028) and kinesiophobia (mean difference: -3.56; 95% CI -1.067 to -0.035) at post-intervention. In the experimental group, improvements were maintained at follow-up assessment for all outcomes, except muscle strength. Conclusion: Adding education to trunk and hip exercises was associated with greater improvements in psychological outcomes than trunk and hip exercises alone after the intervention. Education can be incorporated when designing trunk and hip exercises for patients with PFP. Yes - There is a plan to make this available What will be shared: Only data related to demographic and outcomes information is shared. When: After publishing the article / articles 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 use of documents can only be done provided that their results are presented in systematic review articles conducted by researchers and academic researchers. Necessary conditions for sending data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study 2. A brief and logical explanation of how to use the data or documents 3. Ensuring the registration of the protocol Systematic review studies that have requested access to data or documentation. Where to obtain: Through requesting from 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, South Razan Street, Hesari Street, Keshvari Sport complex
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, South Razan Street, Hesari Street, Keshvari Sport complex
Karaj Iran (Islamic Republic of) 15719-14911 +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi University Iran (Islamic Republic of) Persian native male and female between 18 and 40 years Primary complaint of the anterior knee pain and the symptoms of patellofemoral pain during daily functional activates which is diagnosed by an orthopedic physician 18 years 40 years Both Surgery and /or intra-articular pathology in any lower limb joint knee joint effusion Having physiotherapy treatment for knee pain up to 3 months before participating M22.2 Patellofemoral disorders Rehabilitation Rehabilitation Intervention group: Patient in this group receive 2 supervised sessions for education before stabilization exercises. Each session is provided one-by-one between a patient and allocated physical therapist and lasts approximately between 30 and 45 minutes for each patient. As kinesiophobia and pain catastrophizing are important in patellofemoral pain, each session aims to provide information about the nature of pain to reduce kinesiophobia and avoidance behavior, and consequently to promote self-efficacy. Using explanation and showing pictures, the discussed subjects in each session included: (1) the cause and the reasons behind PFP happening (e.g., main passive and active structures of the knee joint, important roles of the hip joint alignment and musculature); (2) the ways to manage pain (e.g., how to move better during daily activities, preventing knee malalignment [knee valgus] during standing, walking, taking stairs, from sitting to standing, and other activities). For stabilization exercises, exercises are designed for 8 weeks, 3 sessions for each week, and 45 to 60 minutes for each session (the initial 10 minutes for warm-up, and the final 10 minutes for cooldown). Eight weeks of exercise are divided into 3 parts with specific aims. In the first 2 weeks (1st part) the emphasis is on improving motor control of the trunk and hip muscles. In the following 3 weeks (2nd part) the aim is to increase the strength of the trunk and hip muscles and to continue improving motor control using weight-bearing activities. In the last 3 weeks (3rd part) the load is increased, and the exercises became more difficult. Control group: This group receives only stabilization exercises. exercises are designed for 8 weeks, 3 sessions for each week, and 45 to 60 minutes for each session (the initial 10 minutes for warm-up, and the final 10 minutes for cooldown). Eight weeks of exercise are divided into 3 parts with specific aims. In the first 2 weeks (1st part) the emphasis is on improving motor control of the trunk and hip muscles. In the following 3 weeks (2nd part) the aim is to increase the strength of the trunk and hip muscles and to continue improving motor control using weight-bearing activities. In the last 3 weeks (3rd part) the load is increased, and the exercises became more difficult. Pain intensity. Timepoint: Baseline, 8 weeks after intervention, and 3 months follow up. Method of measurement: How to measure a variable is using Visual Analogue Scale. Function. Timepoint: Baseline, 8 weeks after intervention, and 3 months follow up. Method of measurement: Knee outcome survey activities for daily living. Pain Catastrophizing. Timepoint: Baseline, 8 weeks after intervention, and 3 months follow up. Method of measurement: Pain Catastrophizing Scale. Kinesiophobia. Timepoint: Baseline, 8 weeks after intervention, and 3 months follow up. Method of measurement: Tampa Scale for Kinesiophobia. Muscle strength. Timepoint: Baseline, 8 weeks after intervention, and 3 months follow up. Method of measurement: Handheld dynamometer. No governmental fund has been received for this study, and it is conducted by researchers. Approved 2021-06-21 Sport Sciences Research Institute No. 3, 5th Alley, Miremad Street, Motahhari Street Tehran Tehran Iran (Islamic Republic of)