Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome (PHENOPAT)
Primary Purpose
Patellofemoral Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS Radiation
Semi-structured interview
Sponsored by
About this trial
This is an interventional basic science trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral pain syndrome, 3D Kinematics, assessment, clinical phenotypes, dynamic deficiencies
Eligibility Criteria
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)
Sites / Locations
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital CochinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patellofemoral pain syndrome
Arm Description
Kinematic and neuromuscular assessment
Outcomes
Primary Outcome Measures
Amplitude of rotation
Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space
Secondary Outcome Measures
Length measures
EOS femoro-tibial alignment
Q angle (in degree)
EOS femoro-tibial alignment
Varus valgus(in degree)
EOS femoro-tibial alignment
Peak torque (N.m)
Quadriceps isokinetic strenght
Total work (N.m)
Quadriceps isokinetic strenght
Peak torque (N.m)
Hamstrings isokinetic strenght
Total work (N.m)
Hamstrings isokinetic strenght
Quadriceps/Hamstring ratio : 2 measure/leg
Peak torque (N.m)
Hip abductors static strenght
Average torque (N.m)
Hip abductors static strenght
Time for reaching peak (s)
Hip abductors static strenght
Time difference in the onset between the m.vastus lateralis and m.vastus medialis contraction in ms
Activity of the quadriceps measured. Electromyogram was used to quantify the electric potential of quadriceps and referred to as 'quadriceps muscle EMG activity' throughout
Y test
Static and dynamic unipodal balance
Eccentric step-down test
Static and dynamic unipodal balance
Lateral step down test
Static and dynamic unipodal balance
Unipodal stabilometric evaluation
Static and dynamic unipodal balance
Foot posture index
Foot static
Navicular drop test
Foot static
Ober's test
Muscle hypoextensibility. Quadriceps, harmstrings, calves,
Visual Analog Scale
Determine pain / No pain = 0, maximal pain =100
Anterior knee pain scale (AKPS)
Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points
12-Item Short Form Survey (SF-12)
Quality of life, to determine pain
Semi-structured interview
Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.
Full Information
NCT ID
NCT05441332
First Posted
June 14, 2022
Last Updated
September 4, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05441332
Brief Title
Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome
Acronym
PHENOPAT
Official Title
Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome : a Cross-sectional Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Patellofemoral pain syndrome, 3D Kinematics, assessment, clinical phenotypes, dynamic deficiencies
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patellofemoral pain syndrome
Arm Type
Experimental
Arm Description
Kinematic and neuromuscular assessment
Intervention Type
Other
Intervention Name(s)
EOS Radiation
Other Intervention Name(s)
EOS X-ray exams
Intervention Description
One EOS exam of lower extremities
Intervention Type
Behavioral
Intervention Name(s)
Semi-structured interview
Intervention Description
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 Outcome Measure Information:
Title
Amplitude of rotation
Description
Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space
Time Frame
Day of inclusion (up to 10 days)
Secondary Outcome Measure Information:
Title
Length measures
Description
EOS femoro-tibial alignment
Time Frame
Day of inclusion (up to 10 days)
Title
Q angle (in degree)
Description
EOS femoro-tibial alignment
Time Frame
Day of inclusion (up to 10 days)
Title
Varus valgus(in degree)
Description
EOS femoro-tibial alignment
Time Frame
Day of inclusion (up to 10 days)
Title
Peak torque (N.m)
Description
Quadriceps isokinetic strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Total work (N.m)
Description
Quadriceps isokinetic strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Peak torque (N.m)
Description
Hamstrings isokinetic strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Total work (N.m)
Description
Hamstrings isokinetic strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Quadriceps/Hamstring ratio : 2 measure/leg
Time Frame
Day of inclusion (up to 10 days)
Title
Peak torque (N.m)
Description
Hip abductors static strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Average torque (N.m)
Description
Hip abductors static strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Time for reaching peak (s)
Description
Hip abductors static strenght
Time Frame
Day of inclusion (up to 10 days)
Title
Time difference in the onset between the m.vastus lateralis and m.vastus medialis contraction in ms
Description
Activity of the quadriceps measured. Electromyogram was used to quantify the electric potential of quadriceps and referred to as 'quadriceps muscle EMG activity' throughout
Time Frame
Day of inclusion (up to 10 days)
Title
Y test
Description
Static and dynamic unipodal balance
Time Frame
Day of inclusion (up to 10 days)
Title
Eccentric step-down test
Description
Static and dynamic unipodal balance
Time Frame
Day of inclusion (up to 10 days)
Title
Lateral step down test
Description
Static and dynamic unipodal balance
Time Frame
Day of inclusion (up to 10 days)
Title
Unipodal stabilometric evaluation
Description
Static and dynamic unipodal balance
Time Frame
Day of inclusion (up to 10 days)
Title
Foot posture index
Description
Foot static
Time Frame
Day of inclusion (up to 10 days)
Title
Navicular drop test
Description
Foot static
Time Frame
Day of inclusion (up to 10 days)
Title
Ober's test
Description
Muscle hypoextensibility. Quadriceps, harmstrings, calves,
Time Frame
Day of inclusion (up to 10 days)
Title
Visual Analog Scale
Description
Determine pain / No pain = 0, maximal pain =100
Time Frame
Day of inclusion (up to 10 days)
Title
Anterior knee pain scale (AKPS)
Description
Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points
Time Frame
Day of inclusion (up to 10 days)
Title
12-Item Short Form Survey (SF-12)
Description
Quality of life, to determine pain
Time Frame
Day of inclusion (up to 10 days)
Title
Semi-structured interview
Description
Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.
Time Frame
From month 1 to month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra ROREN, PhD, HDR
Phone
0033158411371
Email
alexandra.roren@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie BENHAMMANI-GODARD
Phone
00331 58 41 11 90
Email
marie.godard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin COLEMAN, MSc, PhD student
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital Cochin
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marvin Coleman
Email
marvin.coleman@aphp.fr
First Name & Middle Initial & Last Name & Degree
Alina DUMITRACHE, MD
First Name & Middle Initial & Last Name & Degree
Marie-Martine LEFEVRE COLAU, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome
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