Patellofemoral Pain SyndromeNCT03201133
Clinical Subgroups in Patellofemoral Pain Syndrome
An observational study of Patellofemoral Pain Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Neuromuscular evaluation
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Patellofemoral pain syndrome women
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory
Pôrto Alegre, Rio Grande do Sul, 90690200
About this study
Official title: 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Neuromuscular evaluation
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular evaluationDiagnostic test
(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.
| Study group | Role | What they receive |
|---|---|---|
| Patellofemoral pain syndrome with changes in proximal factors | Not described Receives: Diagnostic Test: Neuromuscular evaluation | |
| Patellofemoral pain syndrome with changes in local factors | Not described Receives: Diagnostic Test: Neuromuscular evaluation | |
| Patellofemoral pain syndrome with changes in distal factors | Not described Receives: Diagnostic Test: Neuromuscular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength tests of hip and knee muscles.
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.
Measured: 1 day
Muscle thickness measures
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.
Measured: 1 day
Muscle activation of knee, hip and foot muscles
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.
Measured: 1 day
Kinematics during unilateral squat
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.
Measured: 1 day
Fascicle length measures
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.
Measured: 1 day
Pennation angle measures
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Sep 2017
- Primary completion25 Oct 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201133
- Sponsor's protocol ID
- UFRGS 1.978.838
- Status last verified
- Apr 2019
- First submitted
- 21 Jun 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Subgroups Identification in Patellofemoral Pain Syndrome Patients
- ClinicalTrials.gov ID
- NCT03201133
- Acronym / sponsor ID
- UFRGS 1.978.838
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patellofemoral pain syndrome with changes in proximal factors | – | Diagnostic Test: Neuromuscular evaluation |
| Patellofemoral pain syndrome with changes in local factors | – | Diagnostic Test: Neuromuscular evaluation |
| Patellofemoral pain syndrome with changes in distal factors | – | Diagnostic Test: Neuromuscular evaluation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patellofemoral pain syndrome women
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular evaluation(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. | Diagnostic test | Patellofemoral pain syndrome with changes in distal factors, Patellofemoral pain syndrome with changes in local factors, Patellofemoral pain syndrome with changes in proximal factors |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength tests of hip and knee muscles. (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.