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NCT Number: NCT07161895

Kinesiophobia and Its Impact on Pain and Function in Knee Osteoarthritis

Knee osteoarthritis (OA) is the most common chronic joint disorder, especially in older adults, and is a leading cause of pain, disability, and reduced quality of life. Patients with OA often experience pain and functional limitations that may contribute to psychological factors such as anxiety, depression, and kinesiophobia (fear of movement). Kinesiophobia is defined as an excessive and irrational fear of movement due to the belief that it will cause pain or re-injury, and it may further limit mobility and daily functioning.

The aim of this prospective, cross-sectional study is to investigate the prevalence of kinesiophobia among patients with primary knee osteoarthritis and to evaluate its relationship with pain severity and functional capacity. A total of 84 participants aged 40-85 years, diagnosed with knee OA, will be recruited from the Department of Physical Medicine and Rehabilitation, Ankara Training and Research Hospital. Data collection will include demographic and clinical information, quadriceps muscle strength, range of motion, and radiographic staging using the Kellgren-Lawrence scale. Outcome measures include the Tampa Scale for Kinesiophobia (TSK), Visual Analogue Scale (VAS) for pain, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function.

This study will provide insights into the impact of kinesiophobia on pain and functional outcomes in knee OA and may help guide clinical strategies that address both physical and psychosocial factors in the management of this common condition.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

About this study

Knee osteoarthritis (OA) is the most prevalent chronic joint disorder, characterized by progressive cartilage degeneration, abnormal remodeling of the subchondral bone, osteophyte formation, and joint pain that frequently results in disability. The knee joint is particularly vulnerable due to its weight-bearing function and high mechanical stress, making knee OA a leading cause of mobility impairment in older adults. While radiographic evaluation using the Kellgren-Lawrence (K/L) grading system remains the standard method for diagnosing and staging OA, radiographic severity does not always correlate with clinical symptoms such as pain and functional disability. This inconsistency suggests that psychosocial factors may play an important role in shaping the clinical presentation of knee OA.

Kinesiophobia, defined as an excessive and irrational fear of movement due to the anticipation of pain or re-injury, has been reported in various musculoskeletal disorders and post-surgical recovery. High levels of kinesiophobia are associated with worse pain perception, reduced functional capacity, and lower quality of life. In knee OA, the role of kinesiophobia remains controversial, with previous studies reporting inconsistent findings regarding its relationship with pain, functional limitation, and disease progression. Understanding this relationship is crucial, as addressing kinesiophobia may help to optimize rehabilitation outcomes and reduce disability in affected patients.

The present study is a prospective, cross-sectional observational study designed to assess the prevalence of kinesiophobia in patients with primary knee osteoarthritis and to examine its association with pain severity and functional status. A total of 84 patients, aged 40-85 years, with radiographically confirmed knee OA will be recruited from the Department of Physical Medicine and Rehabilitation, Ankara Training and Research Hospital. Patients with prior knee surgery, rheumatological disease, neuromuscular conditions, or systemic inflammatory disorders will be excluded.

Data collection will include demographic variables (age, sex, body mass index, occupation, comorbidities), physical examination findings (range of motion, quadriceps strength), and radiographic staging using the Kellgren-Lawrence scale. Patient-reported outcomes will be assessed using the Visual Analogue Scale (VAS) for pain, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function, and the Tampa Scale for Kinesiophobia (TSK), which has been validated in Turkish populations. Higher scores on these measures indicate greater pain, worse functional limitation, and higher levels of kinesiophobia.

All data will be analyzed using SPSS software. Normality will be assessed using the Kolmogorov-Smirnov test. Depending on data distribution, group comparisons will be made with Student's t test or Mann-Whitney U test, and relationships between kinesiophobia, pain, and function will be explored using correlation and regression analyses. A power analysis determined that a minimum of 84 patients will be required to achieve adequate statistical power at 80%.

By systematically evaluating kinesiophobia alongside clinical and radiographic features of knee OA, this study aims to clarify its role as a psychosocial factor influencing pain and disability. The findings are expected to contribute to improved patient assessment and may support the integration of psychological screening and targeted interventions in the management of knee osteoarthritis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 40-85 years
  • Diagnosis of unilateral or bilateral primary knee osteoarthritis
  • Duration of knee pain ≥ 3 months
  • Radiographic confirmation of tibiofemoral OA (Kellgren-Lawrence grading)

Exclusion criteria

  • Prior knee surgery
  • Deep vein thrombosis
  • Neuromuscular disease or neurological disorder
  • Mental illness preventing participation
  • Active infection or osteomyelitis
  • Chronic periarticular infection
  • Rheumatologic disease
  • Immunodeficiency or systemic inflammatory disease
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Kinesiophobia Score (Tampa Scale for Kinesiophobia - TSK)

    Time frame: At baseline, single assessment (Day 1)

    The TSK is a 17-item validated questionnaire assessing fear of movement. Scores range from 17 to 68, with higher scores indicating greater kinesiophobia.

Secondary outcomes

  1. Pain Severity (Visual Analogue Scale - VAS)

    Time frame: At baseline, single assessment (Day 1)

    Pain severity will be measured using a 10 cm-long Visual Analogue Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.

  2. Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC)

    Time frame: At baseline, single assessment (Day 1)

    The WOMAC is a validated 24-item scale assessing pain, stiffness, and physical function. Higher scores indicate greater impairment.

  3. Radiographic Stage (Kellgren-Lawrence Scale)

    Time frame: At baseline, single assessment (Day 1)

    Radiographic severity of knee osteoarthritis will be graded from 0 to 4 according to the Kellgren-Lawrence Scale classification.

  4. Knee Range of Motion (ROM)

    Time frame: At baseline, single assessment (Day 1)

    Measured with a goniometer during physical examination; values reported in degrees.

  5. Quadriceps Muscle Strength

    Time frame: At baseline, single assessment (Day 1)

    Measured using manual muscle testing; results recorded on a 0-5 scale.

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Official study title

Prevalence of Kinesiophobia and Its Effects on Functional Capacity and Pain Severity in Patients With Primary Knee Osteoarthritis

Acronym: KinesiOA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Feb 3, 2026

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

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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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