Anatomical Axis on X-Ray and Its Relationship With Pain and Kinesiophobia in Knee Osteoarthritis
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Pain, Kinesiophobia. Basic parameters: from 18 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 →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Radiographically Evaluated Anatomical Axis on Pain and Kinesiophobia in Knee Osteoarthritis
Overview
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.
Primary outcome measures
- Pain Severity Assessed by Visual Analog Scale (VAS) [Time frame: Day 1 (single assessment at baseline)]
- Kinesiophobia Assessed by Tampa Scale for Kinesiophobia (TSK) [Time frame: Day 1 (single assessment at baseline)]
Secondary outcome measures (4)
- Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: Day 1 (single assessment at baseline)]
- Quality of Life Assessed by Short Form-36 (SF-36) [Time frame: Day 1 (single assessment at baseline)]
- Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA) [Time frame: Day 1 (single assessment at baseline)]
- Joint Space Width (JSW) on Knee X-Ray [Time frame: Day 1 (single assessment at baseline)]
Eligibility criteria
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)
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
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07168590 · KOA2025