- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441332
Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome (PHENOPAT)
Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome : a Cross-sectional Interventional Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Île-de-France Region
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Paris, Île-de-France Region, France, 75014
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patellofemoral pain syndrome
Kinematic and neuromuscular assessment
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One EOS exam of lower extremities
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Amplitude of rotation
Time Frame: Day of inclusion (up to 10 days)
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Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space
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Day of inclusion (up to 10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interview
Time Frame: From month 1 to month 3
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Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.
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From month 1 to month 3
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Length measures
Time Frame: Day of inclusion (up to 10 days)
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EOS femoro-tibial alignment
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Day of inclusion (up to 10 days)
|
|
Q angle (in degree)
Time Frame: Day of inclusion (up to 10 days)
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EOS femoro-tibial alignment
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Day of inclusion (up to 10 days)
|
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Varus valgus(in degree)
Time Frame: Day of inclusion (up to 10 days)
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EOS femoro-tibial alignment
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Day of inclusion (up to 10 days)
|
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Peak torque (N.m)
Time Frame: Day of inclusion (up to 10 days)
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Quadriceps isokinetic strenght
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Day of inclusion (up to 10 days)
|
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Total work (N.m)
Time Frame: Day of inclusion (up to 10 days)
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Quadriceps isokinetic strenght
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Day of inclusion (up to 10 days)
|
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Peak torque (N.m)
Time Frame: Day of inclusion (up to 10 days)
|
Hamstrings isokinetic strenght
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Day of inclusion (up to 10 days)
|
|
Total work (N.m)
Time Frame: Day of inclusion (up to 10 days)
|
Hamstrings isokinetic strenght
|
Day of inclusion (up to 10 days)
|
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Quadriceps/Hamstring ratio : 2 measure/leg
Time Frame: Day of inclusion (up to 10 days)
|
Day of inclusion (up to 10 days)
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Peak torque (N.m)
Time Frame: Day of inclusion (up to 10 days)
|
Hip abductors static strenght
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Day of inclusion (up to 10 days)
|
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Average torque (N.m)
Time Frame: Day of inclusion (up to 10 days)
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Hip abductors static strenght
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Day of inclusion (up to 10 days)
|
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Time for reaching peak (s)
Time Frame: Day of inclusion (up to 10 days)
|
Hip abductors static strenght
|
Day of inclusion (up to 10 days)
|
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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
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Day of inclusion (up to 10 days)
|
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Y test
Time Frame: Day of inclusion (up to 10 days)
|
Static and dynamic unipodal balance
|
Day of inclusion (up to 10 days)
|
|
Eccentric step-down test
Time Frame: Day of inclusion (up to 10 days)
|
Static and dynamic unipodal balance
|
Day of inclusion (up to 10 days)
|
|
Lateral step down test
Time Frame: Day of inclusion (up to 10 days)
|
Static and dynamic unipodal balance
|
Day of inclusion (up to 10 days)
|
|
Unipodal stabilometric evaluation
Time Frame: Day of inclusion (up to 10 days)
|
Static and dynamic unipodal balance
|
Day of inclusion (up to 10 days)
|
|
Foot posture index
Time Frame: Day of inclusion (up to 10 days)
|
Foot static
|
Day of inclusion (up to 10 days)
|
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Navicular drop test
Time Frame: Day of inclusion (up to 10 days)
|
Foot static
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Day of inclusion (up to 10 days)
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Ober's test
Time Frame: Day of inclusion (up to 10 days)
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Muscle hypoextensibility.
Quadriceps, harmstrings, calves,
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Day of inclusion (up to 10 days)
|
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Visual Analog Scale
Time Frame: Day of inclusion (up to 10 days)
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Determine pain / No pain = 0, maximal pain =100
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Day of inclusion (up to 10 days)
|
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Anterior knee pain scale (AKPS)
Time Frame: Day of inclusion (up to 10 days)
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Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points
|
Day of inclusion (up to 10 days)
|
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12-Item Short Form Survey (SF-12)
Time Frame: Day of inclusion (up to 10 days)
|
Quality of life, to determine pain
|
Day of inclusion (up to 10 days)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marvin COLEMAN, MSc, PhD student, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP211433
- 2021-A01928-33 (Other Identifier: France : Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome
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