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NCT Number: NCT06753019

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.

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Key information

Conditions

Knee Osteoarthritis Amplification Anxiety Disorders Arthritis Behavior Behavioral Symptoms Depression Joint Diseases Kinesiophobia Mental Disorders Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Psychological Disability Rheumatic Diseases Signs and Symptoms

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

survey assessment tools

Other

Functional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires.

Primary outcomes

  1. Somatosensory Amplification Scale

    Time frame: up to 2 weeks

    This scale is a 10-item scale developed to measure the magnification/exaggeration that individuals use while somatizing. Each item is scored between 1 and 5. Many of the items include a series of disturbing bodily sensations that are not indicative of illness. The total score is obtained by adding the scores from the items. An increase in the score from the scale indicates that bodily sensations are perceived exaggeratedly.

  2. Tampa Scale for Kinesiophobia

    Time frame: up to 2 weeks

    TSK is a 17-question questionnaire that evaluates fear of re-injury caused by movement, and has been validated and reliable in Turkish. The scale uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Strongly agree). A total score between 17-68 can be obtained based on the answers given by the person as a result of the questionnaire. A high score indicates a high level of kinesiophobia.

  3. Visual Analog Scale

    Time frame: up to 2 weeks

    The VAS is a 10cm line used to measure the intensity of pain, with 'no pain' at one end and 'extreme pain' at the other. Patients mark the point that best describes their pain intensity. The higher the score, the greater the intensity of pain.

  4. Beck Depression Inventory

    Time frame: up to 2 weeks

    BDI is a scale consisting of 21 questions in total used to determine the level of depression. Each question is evaluated between 0 and 3 points. A total score of 10 and above indicates the presence of depression. 10-18 points indicate minor depression, 19-29 points indicate moderate depression, and 30-63 points indicate severe depression.

  5. Western Ontario and McMaster Universities Arthritis Index

    Time frame: up to 2 weeks

    WOMAC is a 24-item scale developed to evaluate pain, joint stiffness, and physical functions in individuals with knee and hip OA. Total scores range from 0 to 96. A high score on the scale indicates high pain, stiffness, and functional limitations.

  6. sociodemographic data form

    Time frame: up to 2 weeks

    Demographic information (age, height, weight, gender) and socio-cultural (educational status, marital status) data of patients will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mesut ERGAN, asst. prof.

CONTACT

[email protected]

+90 02462113730

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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