NCT07161895

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

August 31, 2025

Last Update Submit

January 31, 2026

Conditions

Keywords

KinesiophobiaPainFunctional CapacityWOMACVisual Analogue Scale (VAS)Tampa Scale for Kinesiophobia (TSK)Kellgren-Lawrence Grading

Outcome Measures

Primary Outcomes (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.

    At baseline, single assessment (Day 1)

Secondary Outcomes (5)

  • Pain Severity (Visual Analogue Scale - VAS)

    At baseline, single assessment (Day 1)

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

    At baseline, single assessment (Day 1)

  • Radiographic Stage (Kellgren-Lawrence Scale)

    At baseline, single assessment (Day 1)

  • Knee Range of Motion (ROM)

    At baseline, single assessment (Day 1)

  • Quadriceps Muscle Strength

    At baseline, single assessment (Day 1)

Study Arms (1)

Knee Osteoarthritis Patients

Adults 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.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (17)

  • 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.

    PMID: 39592397BACKGROUND
  • 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.

    PMID: 37482977BACKGROUND
  • 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.

    PMID: 28850536BACKGROUND
  • 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.

    PMID: 38946473BACKGROUND
  • 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.

    PMID: 34324222BACKGROUND
  • 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.

    PMID: 31975503BACKGROUND
  • 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.

    PMID: 39296935BACKGROUND
  • 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.

    PMID: 39041333BACKGROUND
  • 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.

    PMID: 32839826BACKGROUND
  • 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.

    PMID: 38980377BACKGROUND
  • 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.

    PMID: 37914561BACKGROUND
  • 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.

    PMID: 39425703BACKGROUND
  • 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.

    PMID: 34237105BACKGROUND
  • 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.

    PMID: 29666064BACKGROUND
  • 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.

    PMID: 39426272BACKGROUND
  • Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.

    PMID: 33807695BACKGROUND
  • Wu Q, Xu Z, Ma X, Li J, Du J, Ji J, Ling X, Kan J, Zhao M. Association of low muscle mass index and sarcopenic obesity with knee osteoarthritis: a systematic review and meta-analysis. J Int Soc Sports Nutr. 2024 Dec;21(1):2352393. doi: 10.1080/15502783.2024.2352393. Epub 2024 May 22.

    PMID: 38775452BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeKinesiophobiaPain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2025

First Posted

September 9, 2025

Study Start

May 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 30, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations