Investigating the effect of stabilization exercises with and without education on pain, function, and psychological factors in individuals with patellofemoral pain

Comparison of education intervention plus stabilization exercises with stabilization exercises in improving pain, function and, psychological outcomes in patients with patellofemoral pain

Two arm parallel groups randomised trial with blinded outcome assessment

Assessments are in baseline, after 8-week intervention, and 3 months follow-up by a blind assessor. Participants are asked to report their pain and fill out questionnaires for function, pain catastrophizing, and kinesiophobia before the intervention. Muscle strength is evaluated at the laboratory of biomechanics at the university. Education sessions will be held online and exercises will be provided in the health center of the University. Outcome assessor will be blinded to the randomization and group assignment.

Inclusion criteria: Male and female between 18 and 40, complaint of patellofemoral pain during daily activates, diagnosed by an orthopedic physician; exclusion criteria: Surgery and /or intra-articular pathology in any lower limb, joint knee joint effusion, having physiotherapy treatment knee pain up to 3 months before participating.

Experimental group: 2 education sessions for each patient and aims to provide information about the nature of pain to reduce kinesiophobia and avoid behavior, and thus improve self-efficacy. Also, 24 sessions of stabilization training during 8 weeks includes warming up, training and cooling down. Exercises improve the motor control of the trunk and hip muscles, increase the strength of the trunk and hip muscles and making the exercises more difficult. Control group: Only perform stabilization exercises with the same number of sessions, and aims as experimental groupو without education sessions.

Pain, function, Pain Catastrophizing, Kinesiophobia, and lower limbs Muscle strength

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.

In this study, the outcome assessor was blind to the process of randomization and assignment of individuals into experimental and control groups.

Only data related to demographic and outcomes information is shared.

After publishing the article / articles extracted from the study.

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.

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.

Through requesting from Pouya Rabiei: Pouya.rabiei.pr@gmail.com Amir letafatkar: letafatkaramir@yahoo.com Bahram Sheikhi: sheikhibahram@gmail.com

The applicant can request details from the researchers within 7 to 10 days using the message sent by email.