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Treatment Effects on Neuromuscular Properties on Young Women Symptomatic for Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Model 1
Model 2
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral pain, Etiology, Multiarticular rehabilitation, Local factors, Nonlocal factors

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Patellofemoral pain syndrome group:

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

PFPS: Model 1 (Hip and Knee)

PFPS: Model 2 (knee, foot and ankle)

Healthy group

Arm Description

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

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.

Healthy females not submitted to intervention

Outcomes

Primary Outcome Measures

Change of knee pain
Knee pain will be measured with a Numeric Pain Rating Scale (0 to 10)
Self-reported functionality
Self-reported functionality will be measured by Anterior Knee Pain Scale by Kujala Questionaire (1993)
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
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
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
Change of knee muscles, hip muscles, ankle muscles and foot muscles architecture
Muscular architecture (muscle thickness) will be assessed by ultrasonography
Muscle activation
Muscle activation will be assessed by electromyography

Secondary Outcome Measures

Full Information

First Posted
August 30, 2018
Last Updated
March 18, 2022
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03663595
Brief Title
Treatment Effects on Neuromuscular Properties on Young Women Symptomatic for Patellofemoral Pain Syndrome
Official Title
Effects of Two Treatment Models on Neuromuscular Properties of Young Women Symptomatic for Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Healthy females (CG, n=20) were not submited to intervention and PFP participants will be divided into 2 intervention groups (PFPS group, n=66). PFPS Participants' inclusion in the study will be done based on their anamnesis and clinical tests. Participants will be recruited primarily at the School of Physical Education, Physical Therapy and Dance of the Federal University of Rio Grande do Sul (UFRGS). The PFPS group will be submitted to one of two intervention models based on physical exercises, with an 12-week duration, and 2 sessions per week. Model 1 will be composed of exercises focusing on local and proximal factors, and Model 2 will be composed of exercises focused on the PFPS local and distal factors. Only the PFPS group will receive the intervention program. The allocation of each participant's intervention model will be randomized. All participants will be submitted to the following evaluations: (1) anthropometric measurements (mass, height and body mass index), (2) self reported functionality (Kujala Questionnaire), (3) single leg squat and drop landing tests (kinematic analysis), (4) muscle strength (evaluated with a hand held dynamometer), (5) pain (evaluated by numeric pain rating scale), (6) muscle activation (evaluated by EMG) and (7) muscle thickness (evaluated by ultrasonography).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Patellofemoral pain, Etiology, Multiarticular rehabilitation, Local factors, Nonlocal factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFPS: Model 1 (Hip and Knee)
Arm Type
Experimental
Arm Description
Females symptomatic for PFPS. This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.
Arm Title
PFPS: Model 2 (knee, foot and ankle)
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy group
Arm Type
No Intervention
Arm Description
Healthy females not submitted to intervention
Intervention Type
Other
Intervention Name(s)
Model 1
Other Intervention Name(s)
Local and proximal factors
Intervention Description
Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
Intervention Type
Other
Intervention Name(s)
Model 2
Other Intervention Name(s)
Local and distal factors
Intervention Description
Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
Primary Outcome Measure Information:
Title
Change of knee pain
Description
Knee pain will be measured with a Numeric Pain Rating Scale (0 to 10)
Time Frame
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.
Title
Self-reported functionality
Description
Self-reported functionality will be measured by Anterior Knee Pain Scale by Kujala Questionaire (1993)
Time Frame
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.
Title
Change in knee muscles, hip muscles, ankle muscles and foot muscles strength
Description
Torque is an expression of the muscular strength and was assessed by dynamometry
Time Frame
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.
Title
Change of kinematic of pelvis, hip, knee and ankle during single leg squat
Description
Single leg squat will be measured with a video camera, and will be used to determine lower limb alignement
Time Frame
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.
Title
Change of kinematic of pelvis, hip, knee and ankle during drop landing test
Description
rop landing will be measured with a video camera, and will be used to determine lower limb alignement
Time Frame
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.
Title
Change of knee muscles, hip muscles, ankle muscles and foot muscles architecture
Description
Muscular architecture (muscle thickness) will be assessed by ultrasonography
Time Frame
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.
Title
Muscle activation
Description
Muscle activation will be assessed by electromyography
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patellofemoral pain syndrome group: Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Vaz, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36067687
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment Effects on Neuromuscular Properties on Young Women Symptomatic for Patellofemoral Pain Syndrome

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