NCT03201133

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

June 21, 2017

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    1 day

Study Arms (3)

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

Interventions

(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 factorsPatellofemoral pain syndrome with changes in local factorsPatellofemoral pain syndrome with changes in proximal factors

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patellofemoral pain syndrome women

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory

Pôrto Alegre, Rio Grande do Sul, 90690200, Brazil

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 28, 2017

Study Start

September 1, 2017

Primary Completion

October 25, 2017

Study Completion

December 1, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations