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

The Effect of Radiographically Evaluated Anatomical Axis on Pain and Kinesiophobia in Knee Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07168590
Acronym
KOA-AXIS
Enrollment
100
Registered
2025-09-11
Start date
2025-09-08
Completion date
2026-09-08
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinesiophobia, Knee Osteoarthritis, Pain

Keywords

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

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.

Detailed description

Knee osteoarthritis (OA) is a prevalent degenerative joint disease that leads to pain, disability, and reduced quality of life, particularly in older adults. Alterations in lower limb alignment, specifically deviations of the anatomical (mechanical) axis such as varus or valgus deformities, play a key role in the development and progression of OA by altering joint load distribution. Varus alignment is commonly associated with medial compartment OA, whereas valgus alignment is related to lateral compartment OA. Previous studies have reported that such malalignment may accelerate structural damage, increase pain, and contribute to functional impairment. In addition to structural changes, chronic pain in OA patients can lead to fear of movement, known as kinesiophobia, which further limits physical activity and negatively affects functional outcomes. However, there are limited studies that simultaneously evaluate the relationship between radiographic alignment, pain, functional capacity, quality of life, and kinesiophobia. This single-center, observational, cross-sectional study will be conducted at the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The target sample size is 100 patients with knee OA, based on a priori power analysis. Eligible participants must have an anteroposterior knee X-ray taken within the last six months. Pain intensity will be assessed with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the Short Form-36 (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). Radiographic measurements, including femoro-tibial angle and joint space width, will be performed by two independent observers using standardized procedures. Collected data will be analyzed using appropriate statistical methods. The findings are expected to provide a more comprehensive understanding of the relationship between anatomical axis alignment and clinical outcomes in knee OA. This may contribute to more effective treatment planning and patient management.

Interventions

None listed

Sponsors

Selim Sezikli
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Severity Assessed by Visual Analog Scale (VAS)Day 1 (single assessment at baseline)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.
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia (TSK)Day 1 (single assessment at baseline)Fear of movement will be measured with the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire widely used in musculoskeletal conditions.

Secondary

MeasureTime frameDescription
Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Day 1 (single assessment at baseline)Functional status, stiffness, and pain will be assessed using the WOMAC index, a validated tool for patients with knee osteoarthritis.
Quality of Life Assessed by Short Form-36 (SF-36)Day 1 (single assessment at baseline)General health-related quality of life will be evaluated using the SF-36, a standardized questionnaire covering physical, emotional, and social domains.
Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA)Day 1 (single assessment at baseline)The anatomical axis of the lower limb will be measured on standard anteroposterior knee radiographs by two independent observers.
Joint Space Width (JSW) on Knee X-RayDay 1 (single assessment at baseline)Medial and lateral joint space width will be measured on radiographs to evaluate structural severity of knee osteoarthritis.

Countries

Turkey (Türkiye)

Contacts

CONTACTSelim Sezikli, MD
selimsezikli@hotmail.com+90 506 510 18 33
CONTACTCansın Medin Ceylan, Assoc. Prof.
cansinmedin@gmail.com+90 531 575 95 39
PRINCIPAL_INVESTIGATORSelim Sezikli, MD

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026