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Recruiting NCT06753019

Somatosensory Amplification and Psychological and Functional Status In Patients With Knee Osteoarthritis

Observational Knee Osteoarthritis Amplification Kinesiophobia Psychological Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: survey assessment tools.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Amplification, Kinesiophobia, Psychological Disability. Basic parameters: 40 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Relationship Between The Level of Somatosensory Amplification and Psychological and Functional Status in Patients With Knee Osteoarthritis

Overview

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.

Interventions

  • Other survey assessment tools
    Functional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires.

Primary outcome measures

  • Somatosensory Amplification Scale [Time frame: up to 2 weeks]
  • Tampa Scale for Kinesiophobia [Time frame: up to 2 weeks]
  • Visual Analog Scale [Time frame: up to 2 weeks]
  • Beck Depression Inventory [Time frame: up to 2 weeks]
  • Western Ontario and McMaster Universities Arthritis Index [Time frame: up to 2 weeks]
  • sociodemographic data form [Time frame: up to 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Suleyman Demirel University Faculty of Health Science — Isparta

Identifiers

NCT: NCT06753019 · 09-27-2024/80/3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗