Clinical trial NCT06753019: Somatosensory Amplification and Psychological and Functional Status In Patients With Knee Osteoarthritis
Official title: The Relationship Between The Level of Somatosensory Amplification and Psychological and Functional Status in Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Amplification
Kinesiophobia
Psychological Disability
Pain
Keywords: knee osteoarthritis
somatosensory amplification
kinesiophobia
pain
depression
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suleyman Demirel University Research and Application Hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosed with knee OA and had complaints for a minimum of 6 months

Exclusion Criteria:

* any rheumatological disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma

Primary outcomes:
measure: Somatosensory Amplification Scale
timeFrame: up to 2 weeks
measure: Tampa Scale for Kinesiophobia
timeFrame: up to 2 weeks
measure: Visual Analog Scale
timeFrame: up to 2 weeks
measure: Beck Depression Inventory
timeFrame: up to 2 weeks
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: up to 2 weeks
measure: sociodemographic data form
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University Faculty of Health Science
Study officials:
affiliation: Suleyman Demirel University
name: mesut ergan
role: STUDY_DIRECTOR
References: