- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03201133
Clinical Subgroups in Patellofemoral Pain Syndrome
April 16, 2019 updated by: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
Clinical Subgroups Identification in Patellofemoral Pain Syndrome Patients
Patellofemoral pain syndrome (PFPS) is a multifactorial pathology characterized by diffuse retropatellar and peripatellar pain in the knee joint, exacerbated by overloading activities on the patellofemoral joint.
However, this disease showed high degree of patients not responsive to therapeutic strategies.
This condition occurred because several factors is related to disease such as: (1) proximal factors (involving trunk and hip), (2) local factors (surrounding and or within the patellofemoral joint) and (3) distal factors (involving ankle and foot).
Thus, the identification of clinical subgroups based in anatomic changes (proximal, local and distal factors) is a recent strategy that could help in the therapeutic strategies focused on the etiology of the disease, improve responsiveness to treatment, clinical and functional benefits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Pôrto Alegre, Rio Grande Do Sul, Brazil, 90690200
- Exercise Research Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patellofemoral pain syndrome women
Description
Inclusion Criteria:
- Peripatellar or retropatellar pain in at least two of the following situations: squatting, running, kneeling, jumping, climbing or descending stairs and sitting for a prolonged period of time for at least three months.
Exclusion Criteria:
- Engaged in systematic exercise with focus on lower limb in the last six months and Had an injury to the hip and ankle joint in the last 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patellofemoral pain syndrome with changes in proximal factors
|
(1) Muscle trunk endurance test; (2) Hip isometric strength (abductor, lateral rotation, extension); (3) Knee extensor isometric strength; (4) unilateral squat; (5) navicular drop test; (6) muscle architecture at rest of gluteus medius, gluteus maximus,vastus lateralis, vastus medialis and rectus femoris; (7) muscle activation during unilateral squat (gluteus and quadriceps muscles); (8) pennation angle of obliques vastus medialis; (9) medial patellofemoral ligament length; (10) knee pain.
|
|
Patellofemoral pain syndrome with changes in local factors
|
(1) Muscle trunk endurance test; (2) Hip isometric strength (abductor, lateral rotation, extension); (3) Knee extensor isometric strength; (4) unilateral squat; (5) navicular drop test; (6) muscle architecture at rest of gluteus medius, gluteus maximus,vastus lateralis, vastus medialis and rectus femoris; (7) muscle activation during unilateral squat (gluteus and quadriceps muscles); (8) pennation angle of obliques vastus medialis; (9) medial patellofemoral ligament length; (10) knee pain.
|
|
Patellofemoral pain syndrome with changes in distal factors
|
(1) Muscle trunk endurance test; (2) Hip isometric strength (abductor, lateral rotation, extension); (3) Knee extensor isometric strength; (4) unilateral squat; (5) navicular drop test; (6) muscle architecture at rest of gluteus medius, gluteus maximus,vastus lateralis, vastus medialis and rectus femoris; (7) muscle activation during unilateral squat (gluteus and quadriceps muscles); (8) pennation angle of obliques vastus medialis; (9) medial patellofemoral ligament length; (10) knee pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscular strength tests of hip and knee muscles.
Time Frame: 1 day
|
Isometric torque of knee extensor muscles, hip abductor, extension and medial rotation muscles through hand-held dynamometer tests will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
|
Muscle thickness measures
Time Frame: 1 day
|
Muscle thickness (in millimeters) of vastus lateralis, vastus medialis and rectus femoris muscle.
Muscle thickness of gluteus medius, maximus and peroneus muscle through ultrasound equipment.
Tests Test will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
|
Muscle activation of knee, hip and foot muscles
Time Frame: 1 day
|
Muscle activation measures of quadriceps, gluteus maximus, gluteus medius and peroneus muscles during unilateral squat through surface electromyography.
Tests will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
|
Kinematics during unilateral squat
Time Frame: 1 day
|
Pelvis, hip, knee and ankle angular displacement during unilateral squat through kinematics analysis.
Tests will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
|
Fascicle length measures
Time Frame: 1 day
|
Fascicle length (in milimeters) of vastus lateralis, vastus medialis and rectus femoris muscle through ultrasound equipment.
Tests Test will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
|
Pennation angle measures
Time Frame: 1 day
|
Pennation angle (in °) of vastus lateralis, vastus medialis and rectus femoris muscle through ultrasound equipment.
Tests Test will be performed to create clinical subgroups after cluster analysis for a focused intervention in the second step.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
October 25, 2017
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
June 21, 2017
First Submitted That Met QC Criteria
June 26, 2017
First Posted (Actual)
June 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRGS 1.978.838
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
Beijing Sport UniversityCompletedPatellofemoral PainChina
-
Boston Children's HospitalEnrolling by invitationPatellofemoral PainUnited States
-
Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Ahram Canadian UniversityNot yet recruitingPatellofemoral Pain (PFPS)Egypt
-
Beijing Sport UniversityCompletedPatellofemoral Pain, PFPChina
-
Beijing Sport UniversityNot yet recruitingPatellofemoral Pain, PFP
-
Beijing Sport UniversityNot yet recruiting
-
Istanbul University - CerrahpasaRecruitingPatellofemoral Pain, PFPTurkey (Türkiye)
Clinical Trials on Neuromuscular evaluation
-
Karamanoğlu Mehmetbey UniversityCompleted
-
Centre Hospitalier Universitaire DijonTerminated
-
Centre Hospitalier Universitaire de Saint EtienneUniversity of Saint-EtienneWithdrawnChronic Fatigue Syndrome | Intensive Care Unit | MuscleFrance
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedSclerosis, MultipleFrance
-
St. Jude Children's Research HospitalNot yet recruitingMuscle Weakness | Sarcopenia | Low Muscle MassUnited States
-
Istituti Clinici Scientifici Maugeri SpACompletedDiabetes Mellitus, Type 2 | Heart Failure Preserved Ejection FractionItaly
-
University Hospital, GhentCompleted
-
Centre Hospitalier Universitaire de Saint EtienneUniversity of Saint-Etienne; Laboratoire des Adaptations Métaboliques à l'Exercice...TerminatedChronic Fatigue Syndrome | Intensive Care Unit | MuscleFrance
-
Assistance Publique Hopitaux De MarseilleRecruitingCharcot-Marie-Tooth Neuropathy Type 1A | Hereditary Transthyretin Amyloid Neuropathy | Acquired Demyelinating NeuropathyFrance
-
National Taiwan University HospitalRecruitingElectrical Stimulation | Neuromuscular Control | Multidirectional Instability | Hypermobility Spectrum Disorder | Humeral Head TranslationTaiwan