Evaluation of adding Pain neuroscience education to Pilates exercises on reducing on pain and improving function and psychological variables in individuals with knee osteoarthritis

Evaluating if pain neuroscience education plus Pilates exercises will be superior to Pilates exercises on reducing pain and improving function, pain Catastrophizing, kinesiophobia, and self-efficacy in patients with knee OA.

Two arms, randomised trial with blinded outcome assessment

Assessments are before and after interventions through blind assessor. Indexes for pain, pain catastrophizing, kinesiophobia, and self- efficacy are filled by patients online. The function assessment is at biomechanics laboratory at Kharazmi university. Education sessions are online, and Pilates exercises are on the health center of Kharazmi university.

Inclusion criteria: male and female above 45 years old, primary complaint of knee OA by an orthopedic physician. Exclusion criteria: knee replacement or any other lower limb surgery, history of inflammatory, metabolic or neurological disease, knee ligament or meniscus injury

The experimental group includes patients with knee osteoarthritis who receive pain neuroscience education plus Pilates exercises. The control group includes patients with knee osteoarthritis who receive Pilates exercises. Education includes 3 individualized sessions 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.

Pain, function, pain Catastrophizing, kinesiophobia, and self-efficacy

Adding the start and end dates of the actual subject recruitment and the date of study ending.

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.

In this study, the outcome assessor was blinded of the process of randomization and division of individuals into two experimental and control groups.

Only demographic and outcomes-related data will be shared.

After publishing paper(s) 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 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.

Through asking from Authors 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.

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.