Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

— PHENOPAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441332
• Other study ID #: APHP211433
• Secondary ID: 2021-A01928-33
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alexandra ROREN, PhD, HDR
• Phone: 0033158411371
• Email: alexandra.roren[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• EOS Radiation
One EOS exam of lower extremities

Behavioral:
• Semi-structured interview
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.

Locations

Country	Name	City	State
France	Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital Cochin	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of rotation	Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space	Day of inclusion (up to 10 days)
Secondary	Length measures	EOS femoro-tibial alignment	Day of inclusion (up to 10 days)
Secondary	Q angle (in degree)	EOS femoro-tibial alignment	Day of inclusion (up to 10 days)
Secondary	Varus valgus(in degree)	EOS femoro-tibial alignment	Day of inclusion (up to 10 days)
Secondary	Peak torque (N.m)	Quadriceps isokinetic strenght	Day of inclusion (up to 10 days)
Secondary	Total work (N.m)	Quadriceps isokinetic strenght	Day of inclusion (up to 10 days)
Secondary	Peak torque (N.m)	Hamstrings isokinetic strenght	Day of inclusion (up to 10 days)
Secondary	Total work (N.m)	Hamstrings isokinetic strenght	Day of inclusion (up to 10 days)
Secondary	Quadriceps/Hamstring ratio : 2 measure/leg		Day of inclusion (up to 10 days)
Secondary	Peak torque (N.m)	Hip abductors static strenght	Day of inclusion (up to 10 days)
Secondary	Average torque (N.m)	Hip abductors static strenght	Day of inclusion (up to 10 days)
Secondary	Time for reaching peak (s)	Hip abductors static strenght	Day of inclusion (up to 10 days)
Secondary	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	Day of inclusion (up to 10 days)
Secondary	Y test	Static and dynamic unipodal balance	Day of inclusion (up to 10 days)
Secondary	Eccentric step-down test	Static and dynamic unipodal balance	Day of inclusion (up to 10 days)
Secondary	Lateral step down test	Static and dynamic unipodal balance	Day of inclusion (up to 10 days)
Secondary	Unipodal stabilometric evaluation	Static and dynamic unipodal balance	Day of inclusion (up to 10 days)
Secondary	Foot posture index	Foot static	Day of inclusion (up to 10 days)
Secondary	Navicular drop test	Foot static	Day of inclusion (up to 10 days)
Secondary	Ober's test	Muscle hypoextensibility. Quadriceps, harmstrings, calves,	Day of inclusion (up to 10 days)
Secondary	Visual Analog Scale	Determine pain / No pain = 0, maximal pain =100	Day of inclusion (up to 10 days)
Secondary	Anterior knee pain scale (AKPS)	Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points	Day of inclusion (up to 10 days)
Secondary	12-Item Short Form Survey (SF-12)	Quality of life, to determine pain	Day of inclusion (up to 10 days)
Secondary	Semi-structured interview	Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.	From month 1 to month 3