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The Relationship Between The Level of Somatosensory Amplification and Psychological and Functional Status in Patients With Knee Osteoarthritis
As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in correlating these factors with each other and in directing evaluation and treatment programs. Based on this, this study aims to demonstrate the relationship between the level of exaggeration of bodily sensations, psychological-functional status and perceived pain level in patients with knee pain due to knee OA.
This study is a screening study designed to reveal the relationship between the level of somatosensory amplification and the psychological-functional status and the level of pain felt in patients with knee pain due to knee OA. Considering the correlation of the features to be examined in the literature, it was found that the required sample size should be at least 80 with a test power of 95%, a type I error of 0.05 and an effect size of 0.34. 88 patients between the ages of 40-84 who have been diagnosed with knee OA and have complaints for at least 6 months will be included in the study. Patients with knee pain due to any rheumatologic disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma will be excluded from the study. The patients' sociodemographic characteristics such as age, height, weight, body mass index (BMI), gender, education level, marital status will be evaluated using the sociodemographic information form, somatosensory amplification levels will be evaluated with the 'Somatosensory Amplification Scale (SSAS)', the presence of kinesiophobia with the 'Tampa Kinesiophobia Scale (TSK)', pain levels with the Visual Analog Scale (VAS), the presence of depression with the 'Beck Depression Inventory (BDI)', and functional status with the total score of the 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)'. Statistical analysis of the data will be done using IBM SPSS Statistics version 20.0 (SPSS Inc., New York, USA). Kolmogorov-Smirnov test will be used to determine whether the variables are normally distributed, and the socio-demographic information of the participants and the scores they received from the SSAS, TAMPA, VAS, BDI and WOMAC questionnaires will be expressed as percentages, ratios or averages. The linear relationship between quantitative variables will be analyzed with Pearson correlation analysis, and the correlation between qualitative and quantitative variables will be analyzed with variance analysis (ANOVA), and independent samples t-test. In all analyses, p\<0.05 will be considered statistically significant.
Age
40 - 84 years
Sex
ALL
Healthy Volunteers
No
Suleyman Demirel University Faculty of Health Science
Isparta, Turkey (Türkiye)
Start Date
October 1, 2024
Primary Completion Date
December 30, 2024
Completion Date
January 10, 2025
Last Updated
December 31, 2024
80
ESTIMATED participants
survey assessment tools
OTHER
Lead Sponsor
Suleyman Demirel University
NCT07351968
NCT06747494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06906939