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

NCT06753019 | Recruiting

• 1 other identifier: 09-27-2024/80/3
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Amplification; Kinesiophobia; Psychological Disability; Pain

Keywords

knee osteoarthritis; somatosensory amplification; kinesiophobia; pain; depression

Outcome Measures

Primary Outcomes (6)

• Somatosensory Amplification Scale

  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.

  up to 2 weeks

• Tampa Scale for Kinesiophobia

  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.

  up to 2 weeks

• Visual Analog Scale

  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.

  up to 2 weeks

• Beck Depression Inventory

  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.

  up to 2 weeks

• Western Ontario and McMaster Universities Arthritis Index

  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.

  up to 2 weeks

• sociodemographic data form

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

  up to 2 weeks

Study Arms (1)

assessment group

Patients diagnosed with knee OA, who have complaints for at least 6 months, and between the ages of 40-84 will be included in the study.

Other: survey assessment tools

Interventions

survey assessment tools OTHER

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

assessment group

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suleyman Demirel University Research and Application Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University Faculty of Health Science

Isparta, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Kinesiophobia; Pain; Depression

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• mesut ergan

  Suleyman Demirel University

  STUDY DIRECTOR

Central Study Contacts

Mesut ERGAN, asst. prof.

CONTACT

+90 02462113730; mesutergan@sdu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 31, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 10, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)