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Knee Osteoarthritis (Knee OA)KinesiOANCT07161895

Kinesiophobia and Its Impact on Pain and Function in Knee Osteoarthritis

An observational study of Knee Osteoarthritis (Knee OA) and OA, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Knee Osteoarthritis (Knee OA), OA, Kinesiophobia
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 30 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults aged 40-85 years with radiographically confirmed primary knee osteoarthritis, recruited from the Physical Medicine and Rehabilitation Clinic of Ankara Training and Research Hospital.

Who may be able to join

  • 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)

Who cannot join

  • Prior knee surgery
  • Deep vein thrombosis
  • Neuromuscular disease or neurological disorder
  • Mental illness preventing participation
  • Active infection or osteomyelitis
  • Chronic periarticular infection
Show all 9Show fewer
  • Rheumatologic disease
  • Immunodeficiency or systemic inflammatory disease
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

    Ankara, Altindag, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence of Kinesiophobia and Its Effects on Functional Capacity and Pain Severity in Patients With Primary 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.

Read the detailed description

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.

Keywords
Kinesiophobia, Pain, Functional Capacity, WOMAC, Visual Analogue Scale (VAS), Tampa Scale for Kinesiophobia (TSK), Kellgren-Lawrence Grading
Medical subject headings
Osteoarthritis, Knee, Kinesiophobia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07161895
Study groupRoleWhat they receive
Knee Osteoarthritis PatientsAdults aged 40-85 years with radiographically confirmed primary knee osteoarthritis. Participants will complete clinical examination, Kellgren-Lawrence radiographic grading, Visual Analogue Scale (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function, and Tampa Scale for Kinesiophobia (TSK). Assessments are performed at a single visit; no interventions are applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: At baseline, single assessment (Day 1)

Secondary outcomes (5)
  1. Pain Severity (Visual Analogue Scale - VAS)

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

    Measured: At baseline, single assessment (Day 1)

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

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

    Measured: At baseline, single assessment (Day 1)

  3. Radiographic Stage (Kellgren-Lawrence Scale)

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

    Measured: At baseline, single assessment (Day 1)

  4. Knee Range of Motion (ROM)

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

    Measured: At baseline, single assessment (Day 1)

  5. Quadriceps Muscle Strength

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

    Measured: At baseline, single assessment (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start1 May 2025
  3. Primary completion15 Jan 2026
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161895
Sponsor's protocol ID
AnkaraTRH-FTR-NK-08
Other IDs
E-25-543
Acronym
KinesiOA
Status last verified
Jan 2026
First submitted
31 Aug 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the study is observational, involves a single-center hospital population, and collects sensitive clinical and psychosocial information that cannot be adequately de-identified for open sharing. Aggregate results will be reported in publications.

Publications

  • Canzone A, Roggio F, Patti A, Giustino V, Mannucci C, Di Mauro D, Musumeci G, Bianco A, Trimarchi F. Classification of Physical Activity Programs Based on the Kellgren & Lawrence Scale for Knee Osteoarthritis: A Systematic Review. Musculoskeletal Care. 2024 Dec;22(4):e70019. doi: 10.1002/msc.70019.

    PubMed 39592397
  • Ege F. The relationship between kinesiophobia severity and clinical parameters in patients with mechanical low back pain. J Back Musculoskelet Rehabil. 2024;37(2):285-294. doi: 10.3233/BMR-220365.

    PubMed 37482977
  • Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.

    PubMed 28850536
  • Peral Perez J, Mortensen SR, Lluch Girbes E, Gronne DT, Thorlund JB, Roos EM, Skou ST. Association between widespread pain and psychosocial factors in people with knee osteoarthritis: a cross-sectional study of patients from primary care in Denmark. Physiother Theory Pract. 2025 Apr;41(4):752-762. doi: 10.1080/09593985.2024.2372381. Epub 2024 Jul 1.

    PubMed 38946473
  • Aydemir B, Huang CH, Foucher KC. Strength and physical activity in osteoarthritis: The mediating role of kinesiophobia. J Orthop Res. 2022 May;40(5):1135-1142. doi: 10.1002/jor.25151. Epub 2021 Aug 6.

    PubMed 34324222
  • Molyneux J, Herrrington L, Riley B, Jones R. A single-arm, non-randomized investigation into the short-term effects and follow-up of a 4-week lower limb exercise programme on kinesiophobia in individuals with knee osteoarthritis. Physiother Res Int. 2020 Jul;25(3):e1831. doi: 10.1002/pri.1831. Epub 2020 Jan 24.

    PubMed 31975503
  • Lisboa FSS, Benevento EM, Kaneko LO, Bertolucci V, Rosini Silva AA, Sardim AC, Ruiz VF, Dos Reis IGM, Porcari AM, Messias LHD. Plasma metabolites associated with biopsychosocial parameters in overweight/obese women with severe knee osteoarthritis. Front Cell Dev Biol. 2024 Sep 4;12:1454084. doi: 10.3389/fcell.2024.1454084. eCollection 2024.

    PubMed 39296935
  • Nedder VJ, Raju AG, Moyal AJ, Calcei JG, Voos JE. Impact of Psychological Factors on Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Sports Health. 2025 Mar;17(2):291-298. doi: 10.1177/19417381241256930. Epub 2024 Jul 23.

    PubMed 39041333
  • Brown OS, Hu L, Demetriou C, Smith TO, Hing CB. The effects of kinesiophobia on outcome following total knee replacement: a systematic review. Arch Orthop Trauma Surg. 2020 Dec;140(12):2057-2070. doi: 10.1007/s00402-020-03582-5. Epub 2020 Aug 24.

    PubMed 32839826
  • Fischer M, Nonnenmacher L, Sobau C, Zimmerer A. Postoperative hip bracing reduces kinesiophobia in patients undergoing hip arthroscopy: a randomized-controlled trial. Arch Orthop Trauma Surg. 2024 Jul;144(7):3205-3210. doi: 10.1007/s00402-024-05437-9. Epub 2024 Jul 9.

    PubMed 38980377
  • Han S, Oh M, Lee H, Hopkins JT. The effects of kinesiophobia on postural control with chronic ankle instability. Gait Posture. 2024 Jan;107:269-274. doi: 10.1016/j.gaitpost.2023.10.014. Epub 2023 Oct 18.

    PubMed 37914561
  • Reddy RS, Alshahrani MS, Tedla JS, Dixit S, Gular K, Kakaraparthi VN. Exploring the Interplay Between Kinesiophobia, Lumbar Joint Position Sense, Postural Stability, and Pain in Individuals With Chronic Low Back Pain: A Cross-Sectional Analysis. J Manipulative Physiol Ther. 2023 Jun-Dec;46(5-9):294-304. doi: 10.1016/j.jmpt.2024.09.004. Epub 2024 Oct 16.

    PubMed 39425703
  • Asiri F, Reddy RS, Tedla JS, ALMohiza MA, Alshahrani MS, Govindappa SC, Sangadala DR. Kinesiophobia and its correlations with pain, proprioception, and functional performance among individuals with chronic neck pain. PLoS One. 2021 Jul 8;16(7):e0254262. doi: 10.1371/journal.pone.0254262. eCollection 2021.

    PubMed 34237105
  • Luque-Suarez A, Martinez-Calderon J, Falla D. Role of kinesiophobia on pain, disability and quality of life in people suffering from chronic musculoskeletal pain: a systematic review. Br J Sports Med. 2019 May;53(9):554-559. doi: 10.1136/bjsports-2017-098673. Epub 2018 Apr 17.

    PubMed 29666064
  • Lozano-Meca J, Gacto-Sanchez M, Montilla-Herrador J. Association of kinesiophobia with pain, disability and functional limitation in adults with knee osteoarthritis: A systematic review and meta-analysis. Geriatr Nurs. 2024 Nov-Dec;60:481-490. doi: 10.1016/j.gerinurse.2024.10.013. Epub 2024 Oct 18.

    PubMed 39426272

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis (Knee OA) and OA, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinesiophobia Score (Tampa Scale for Kinesiophobia - TSK) (time frame: At baseline, single assessment (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07161895, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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