NCT03663595

Brief Summary

Patellofemoral Pain Syndrome (PFPS) is characterized by diffuse pain around the knee joint. This presence of pain is the most common manifestation in sports medicine among adults and young people. Women are more likely to develop PFPS. Among the young adult population, it is estimated that 13% of the women are affected by PFPS. There is a consensus among clinicians that PFPS etiology is multifactorial, including local factors (structures present or acting directly on the patellofemoral joint) and nonlocal factors \[extrinsic to the patellofemoral joint, including proximal factors (hip, trunk and pelvis), and distal factors (ankle and foot)\]. PFPS is not a degenerative syndrome, and conservative treatment offers good results. However, the most appropriate therapeutic approach is still unclear, and the rate of nonresponders to treatment is high. One of the possible explanations for failure of the therapeutic intervention is that the triggering mechanisms of PFPS are not the same for all subjects, and probably some patients cannot be reached by standard treatment. The traditional intervention model focuses on the strengthening of the knee extensor muscles, but recent literature has pointed out that multi-articular treatment models (i.e., exercises for the proximal or distal factors, in addition to exercises for the quadriceps) have shown better results. It is believed that the elaboration of treatment protocols combining local and non-local factors, present greater responsiveness and results retention, thus reducing treatment failure. Based on this, and due to the lack of experimental studies that aimed to compare the effects of a multi-articular intervention protocol combining local and non-local factors in women affected by PFPS, this study aims to evaluate the effects of two multi-articular intervention protocols based on exercises (1) for the proximal and local factors versus (2) for the distal and local factors on the clinical, functional and neuromechanical outcomes of young women with PFPS. Participants of the PFPS group will be submitted to one of two intervention models for an 12-week rehabilitation program. Model 1 will be composed of exercises focusing on local and proximal PFPS factors, and Model 2 will be composed of exercises focused on the local and distal factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

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

August 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

August 30, 2018

Last Update Submit

March 18, 2022

Conditions

Keywords

Patellofemoral painEtiologyMultiarticular rehabilitationLocal factorsNonlocal factors

Outcome Measures

Primary Outcomes (7)

  • Change of knee pain

    Knee pain will be measured with a Numeric Pain Rating Scale (0 to 10)

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Self-reported functionality

    Self-reported functionality will be measured by Anterior Knee Pain Scale by Kujala Questionaire (1993)

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Change in knee muscles, hip muscles, ankle muscles and foot muscles strength

    Torque is an expression of the muscular strength and was assessed by dynamometry

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Change of kinematic of pelvis, hip, knee and ankle during single leg squat

    Single leg squat will be measured with a video camera, and will be used to determine lower limb alignement

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Change of kinematic of pelvis, hip, knee and ankle during drop landing test

    rop landing will be measured with a video camera, and will be used to determine lower limb alignement

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Change of knee muscles, hip muscles, ankle muscles and foot muscles architecture

    Muscular architecture (muscle thickness) will be assessed by ultrasonography

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

  • Muscle activation

    Muscle activation will be assessed by electromyography

    The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.

Study Arms (3)

PFPS: Model 1 (Hip and Knee)

EXPERIMENTAL

Females symptomatic for PFPS. This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.

Other: Model 1

PFPS: Model 2 (knee, foot and ankle)

EXPERIMENTAL

Females symptomatic for PFPS This group will be submitted to the rehabilitation program with exercises focusing in distal (foot and ankle) and local (knee) factors.

Other: Model 2

Healthy group

NO INTERVENTION

Healthy females not submitted to intervention

Interventions

Model 1OTHER

Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.

Also known as: Local and proximal factors
PFPS: Model 1 (Hip and Knee)
Model 2OTHER

Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.

Also known as: Local and distal factors
PFPS: Model 2 (knee, foot and ankle)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A physiotherapist evaluated PFP participants' eligibility based on the following criteria: (1) presence of peripatelar or retropatelar pain in at least two functional tasks (squatting, running, kneeling, jumping, climbing or descending stairs, sitting for a long time, sitting with knees flexed), (2) ongoing patellar pain for at least 3 months, (3) PFP with a minimum of 3 out of 10 points in the numeric rating scale for knee pain (0 = "no pain", 10 = "intolerable pain"), (4) beginning of PFP symptoms not related to trauma and (5) not participating in any PFP treatment in the last 12 months

You may not qualify if:

  • Participants were excluded if they presented signs or symptoms of (1) meniscal or other intra-articular pathologies; (2) signs of patellar apprehension; (3) history of hip, knee, or ankle joint injury; (4) evidence of joint effusion; and (5) history of patellofemoral joint surgery.
  • Healthy group (n=20): women with no history of PFP in the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (1)

  • Pompeo KD, da Rocha ES, Melo MA, de Oliveira NT, Oliveira DF, Sonda FC, Dos Santos PF, Rodrigues R, Baroni BM, Vaz MA. Can we replace exercises targeted on core/hip muscles by exercises targeted on leg/foot muscles in women with patellofemoral pain? A randomized controlled trial. Phys Ther Sport. 2022 Nov;58:1-7. doi: 10.1016/j.ptsp.2022.08.004. Epub 2022 Aug 28.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Marco Vaz, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 10, 2018

Study Start

October 1, 2018

Primary Completion

December 20, 2019

Study Completion

July 30, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations