Anatomical Axis on X-Ray and Its Relationship With Pain and Kinesiophobia in Knee Osteoarthritis

NCT07168590 | Recruiting

• 1 other identifier: KOA2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. This study aims to investigate the relationship between the anatomical axis measured on knee X-rays and patients' pain levels, functional status, quality of life, and fear of movement (kinesiophobia). This is a single-center, observational, cross-sectional study. Adult patients diagnosed with knee osteoarthritis who have a standard knee X-ray taken within the last 6 months and who volunteer to participate will be included. Pain will be measured with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the 36-Item Short Form Health Survey (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). The femoro-tibial angle and joint space width will be measured on X-rays by two independent observers. By examining the relationship between radiographic alignment and clinical findings, this study may provide new insights into the comprehensive evaluation of knee osteoarthritis and help guide treatment planning for patients.

Conditions

Pain; Kinesiophobia; Knee Osteoarthritis

Keywords

Knee osteoarthritis; Anatomical axis; Radiographic alignment; Tampa Scale for Kinesiophobia (TSK); SF-36; WOMAC; Pain; Femoro-tibial angle; Kinesiophobia

Outcome Measures

Primary Outcomes (2)

• Pain Severity Assessed by Visual Analog Scale (VAS)

  Pain intensity during daily activities will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain.

  Day 1 (single assessment at baseline)

• Kinesiophobia Assessed by Tampa Scale for Kinesiophobia (TSK)

  Fear of movement will be measured with the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire widely used in musculoskeletal conditions.

  Day 1 (single assessment at baseline)

Secondary Outcomes (4)

• Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Day 1 (single assessment at baseline)

• Quality of Life Assessed by Short Form-36 (SF-36)

  Day 1 (single assessment at baseline)

• Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA)

  Day 1 (single assessment at baseline)

• Joint Space Width (JSW) on Knee X-Ray

  Day 1 (single assessment at baseline)

Study Arms (1)

Knee Osteoarthritis Patients

This cohort includes adult patients diagnosed with knee osteoarthritis who meet the inclusion criteria. All participants will undergo clinical evaluation of pain, functional status, quality of life, and kinesiophobia using validated scales (VAS, WOMAC, SF-36, TSK). Radiographic assessment will be performed on existing anteroposterior knee X-rays taken within the last 6 months, including femoro-tibial angle and joint space width measurements. No experimental intervention will be applied; data will be collected in an observational and cross-sectional manner.

Eligibility Criteria

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

Study Population

Adult patients diagnosed with knee osteoarthritis who are admitted to the Physical Medicine and Rehabilitation outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants must have a knee X-ray taken within the last 6 months and meet the study's eligibility criteria.

You may qualify if:

• Diagnosis of knee osteoarthritis (clinical and radiographic)
• Having an anteroposterior knee X-ray taken within the last 6 months
• Voluntary agreement to participate in the study
• Cognitive ability sufficient to understand test instructions

You may not qualify if:

• History of knee surgery
• Illiteracy (inability to read/write)
• Refusal to participate
• Presence of orthopedic conditions that prevent walking (e.g., amputation, joint prosthesis)

Sponsors & Collaborators

• Selim Sezikli: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

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

Study Officials

• Selim Sezikli, MD

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Sezikli, MD

CONTACT

+90 506 510 18 33; selimsezikli@hotmail.com

Cansın Medin Ceylan, Assoc. Prof.

CONTACT

+90 531 575 95 39; cansinmedin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: September 8, 2025
• Primary Completion: March 8, 2026
• Study Completion: March 8, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents (protocol, SAP, ICF) will be available beginning 6 months after study completion (September 2026) and will remain available for up to 2 years (until March 2028).
• Access Criteria: Qualified researchers with approval from an independent ethics committee and a signed data use agreement will be granted access to de-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form). Data will be shared in anonymized format to ensure patient confidentiality. Access requests should be submitted to the principal investigator, and data will be provided electronically after approval.

Locations

TU (1)