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Completed

NCT Number: NCT05441332

Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome

The purpose of this study is to describe and compare the kinematic deficiencies specifically associated with each of the 3 main clinical phenotypes of patellofemoral pain syndrome. The prevalence of patellofemoral pain is high with a high rate of chronicity and recurrence and an overrepresentation of young, athletic and female populations. There are multiple classifications of patellofemoral pain syndrome. A pragmatic classification distinguishes 3 main clinical phenotypes of patellofemoral pain syndrome: with objectively displaceable patella, with extra-patellar alignment problems and without alignment problems.

The pathophysiology of patellofemoral pain syndrome is multifactorial involving static and dynamic dysfunctions of the hip, knee and foot, which remain incompletely elucidated to date. The links between the clinical and biomechanical aspects are still unclear and the kinematic and neuromuscular deficiencies associated with the 3 main clinical phenotypes are poorly understood. A validated non-invasive device allows the 3D evaluation of femorotibial rotations during walking.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital Cochin

Paris, Île-de-France Region, 75014, France

About this study

The diagnostic process is based on clinical examination. The evolution of measuring tools like radios, RMI and kinematics device allows a more precise diagnostic of patellofemoral Pain syndrome. We still don't know what kind of gait parameters could help to categorize the different phenotypes. With a better understanding of these phenotypes the investigators will be able to propose a better personalized rehabilitation.

Patellofemoral pain syndrome is defined as an anterior knee pain in front of and around the patella. The diagnosis of patellofemoral pain syndrome is based on clinical examination and standard imaging.

The pathophysiology of the patellofemoral pain syndrome is multifactorial involving static and dynamic dysfunctions of the hip, knee and foot, which remain incompletely elucidated to date. The prevalence of patellofemoral pain is high with a high rate of chronicity and recurrence and an overrepresentation of young, athletic and female populations. A pragmatic classification distinguishes 3 main clinical phenotypes of patellofemoral pain syndrome: with objectively displaceable patella, with extra-patellar alignment problems and without alignment problems.

The links between the clinic and biomechanics are still unclear and the kinematics and neuromuscular impairments associated with the 3 main clinical phenotypes are poorly understood.

The KneeKG is an optoelectronic kinematic assessment device using non-invasive sensors and dedicated to real-time measurement of 3D femoro-tibial position and rotations. The kinematic, neuro-muscular, postural and proprioceptive assessments will allow us to better understand the pathophysiology of the patellofemoral pain syndrome, to establish a more accurate diagnosis of the disease, and provide a better understanding of its causes.

Several studies have shown that better adherence to exercise is associated with greater benefit in terms of pain and function in chronic pathologies.

Semi-structured interviews will enable the investigators to assess the impact of information derived from kinematic examination of the knees on adherence to treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical diagnosis of SDFP :
  • Anterior pain of the knee, mechanical, in front of and around the patella noted at more than 3/10 on a simple numerical scale (ligament or meniscal damage, synovial plicae, tendinopathies, apophysitis, neuromas, and osteoarthritis FT are differential diagnoses),
  • Pain during any of the following activities: Going up / down stairs, squats, jumps, jogging, sitting, crouching.
  • Duration of knee anterior pain greater than 1 month
  • Affiliation to a social insurance
  • Signature of the consent to participate

Exclusion criteria

  • Neurological disorders affecting the lower extremities
  • Radiographic FT osteoarthritis
  • History of surgery or trauma to the lower limb less than 1 year old
  • Intra-articular knee infiltration ≤ 2 months
  • Cognitive or behavioral problems making it impossible to assess
  • Participates in intervention research or is in the exclusion period following a previous research, if applicable
  • Unable to speak, read and write French
  • Patients under guardianship or curatorship,
  • Patients receiving AME (French State Medical aid)

Treatment and study plan

EOS Radiation

Other

One EOS exam of lower extremities

Other names: EOS X-ray exams

Semi-structured interview

Behavioral

Semi-structured interview to identify factors influencing patient adherence behavior for a sub-group of 15 patients. By phone, between 1 to 3 months after inclusion.

Primary outcomes

  1. Amplitude of rotation

    Time frame: Day of inclusion (up to 10 days)

    Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space

Secondary outcomes

  1. Length measures

    Time frame: Day of inclusion (up to 10 days)

    EOS femoro-tibial alignment

  2. Q angle (in degree)

    Time frame: Day of inclusion (up to 10 days)

    EOS femoro-tibial alignment

  3. Varus valgus(in degree)

    Time frame: Day of inclusion (up to 10 days)

    EOS femoro-tibial alignment

  4. Peak torque (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Quadriceps isokinetic strenght

  5. Total work (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Quadriceps isokinetic strenght

  6. Peak torque (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Hamstrings isokinetic strenght

  7. Total work (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Hamstrings isokinetic strenght

  8. Quadriceps/Hamstring ratio : 2 measure/leg

    Time frame: Day of inclusion (up to 10 days)

  9. Peak torque (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Hip abductors static strenght

  10. Average torque (N.m)

    Time frame: Day of inclusion (up to 10 days)

    Hip abductors static strenght

  11. Time for reaching peak (s)

    Time frame: Day of inclusion (up to 10 days)

    Hip abductors static strenght

  12. Time difference in the onset between the m.vastus lateralis and m.vastus medialis contraction in ms

    Time frame: Day of inclusion (up to 10 days)

    Activity of the quadriceps measured. Electromyogram was used to quantify the electric potential of quadriceps and referred to as 'quadriceps muscle EMG activity' throughout

  13. Y test

    Time frame: Day of inclusion (up to 10 days)

    Static and dynamic unipodal balance

  14. Eccentric step-down test

    Time frame: Day of inclusion (up to 10 days)

    Static and dynamic unipodal balance

  15. Lateral step down test

    Time frame: Day of inclusion (up to 10 days)

    Static and dynamic unipodal balance

  16. Unipodal stabilometric evaluation

    Time frame: Day of inclusion (up to 10 days)

    Static and dynamic unipodal balance

  17. Foot posture index

    Time frame: Day of inclusion (up to 10 days)

    Foot static

  18. Navicular drop test

    Time frame: Day of inclusion (up to 10 days)

    Foot static

  19. Ober's test

    Time frame: Day of inclusion (up to 10 days)

    Muscle hypoextensibility. Quadriceps, harmstrings, calves,

  20. Visual Analog Scale

    Time frame: Day of inclusion (up to 10 days)

    Determine pain / No pain = 0, maximal pain =100

  21. Anterior knee pain scale (AKPS)

    Time frame: Day of inclusion (up to 10 days)

    Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points

  22. 12-Item Short Form Survey (SF-12)

    Time frame: Day of inclusion (up to 10 days)

    Quality of life, to determine pain

  23. Semi-structured interview

    Time frame: From month 1 to month 3

    Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome : a Cross-sectional Interventional Study

Acronym: PHENOPAT

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
Jul 1, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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