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

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ClinicalTrials.gov Identifier: NCT03663595
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul

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 based on the PFPS etiological factors, 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 on specific subgroups 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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Model 1 Other: Model 2 Not Applicable

Detailed Description:
Participants will be divided into 2 groups (control group: n=15 and PFPS group, n=60). Participants of the PFPS group will be classified according to their PFPS etiological factors, and as a function of changes at proximal or distal factors. Participants' inclusion in the study will be done based on their anamnesis, clinical tests, functional tests and strength measures. 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, and every intervention model will have 2 participants' groups (group with proximal factors and group with local factors). 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 thigh length), (2) clinical tests (Compression Test and Kujala Questionnaire), (3) single leg squat (kinematic analysis), (4) muscle mechanical properties of the knee extensors, external hip rotators, hip extensors, hip abductors, ankle plantar and dorsal flexors, foot pronators and supinators [evaluated with a manual (Microfet 2) or isokinetic dynamometer (Biodex System 3 Pro)], (5) myoelectric properties [evaluated by electromyography (Delsys system)], (6) drop landing test (kinematic analysis), (7) patellofemoral cartilage thickness (evaluated by ultrasonography), and (8) muscle architecture of the knee extensors, external hip rotators, hip extensors, hip abductors, ankle plantar and dorsal flexors, and foot pronators and supinators (evaluated by ultrasonography

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Two Treatment Models on Neuromuscular Properties of Young Women Symptomatic for Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Actual Study Start Date : August 9, 2018
Actual Primary Completion Date : August 25, 2018
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
No Intervention: Control Group
Females asymptomatic for patellofemoral pain syndrome
Experimental: PFPS: Proximal factors - Model 1 (Hip and Knee)
Females symptomatic for PFPS with modification in proximal factors related to patellofemoral pain. This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.
Other: Model 1
Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
Other Name: Local and proximal factors

Experimental: PFPS: Proximal factors - Model 2 (knee, foot and ankle)
Females symptomatic for PFPS with modification in proximal factors related to patellofemoral pain. This group will be submitted to the rehabilitation program with exercises focusing in distal (foot and ankle) and local (knee) factors.
Other: Model 2
Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
Other Name: Local and distal factors

Experimental: PFPS: Distal factors - Model 1(Hip and Knee)
Females symptomatic for PFPS with modification in distal factors related to patellofemoral pain. This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.
Other: Model 1
Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
Other Name: Local and proximal factors

Experimental: AKP: Distal factors - Model 2 (knee, foot and ankle)
Females symptomatic for PFPS with modification in distal factors related to patellofemoral pain. This group will be submitted to the rehabilitation program with exercises focusing in local (knee) and distal (foot and ankle) factors.
Other: Model 2
Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
Other Name: Local and distal factors




Primary Outcome Measures :
  1. Change in knee muscles, hip muscles, ankle muscles and foot muscles strength (measured by joint torque, obtained 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. ]
    Torque is an expression of the muscular strength and was assessed by dynamometry

  2. Change of knee muscles, hip muscles, ankle muscles and foot muscles architecture [ 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. ]
    Muscular architecture (muscle thickness, pennation angle and fascicle length) will be assessed by ultrasonography

  3. CChange of knee muscles, hip muscles, ankle muscles and foot muscles electrical activation [ 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. ]
    Electrical activation will be assessed by surface electromyography (EMG)

  4. Change of patellofemoral cartilage thickness [ 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. ]
    Patellofemoral cartilage thickness will be assessed by ultrasonography

  5. Change of kinematic of pelvis, hip, knee and ankle during single leg squat [ 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. ]
    Single leg squat will be measured with a video camera, and will be used to determine lower limb functionality

  6. Change of kinematic of pelvis, hip, knee and ankle during drop landing test [ 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. ]
    Drop landing will be measured with a video camera, and will be used to determine lower limb functionality

  7. Change of knee pain through Visual Analogue Scale [ 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. ]
    Knee pain will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.

  8. Change of Navicular Drop test [ 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. ]
    Navicular drop height (standing and siting) will be measured with a photograph obtained at the sagittal plane



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Patellofemoral pain syndrome group:

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

Control group: Healthy subjects assymptomatic for patellofemoral pain and no injury to the hip and ankle joint in the last 12 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663595


Contacts
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Contact: Marco Vaz, PhD +555133085860 marco.vaz@ufrgs.br
Contact: Klauber Pompeo, MsC +5551993463917 kdpompeo@yahoo.com.br

Locations
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Brazil
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
Principal Investigator: Marco A Vaz, PhD         
Sub-Investigator: Klauber Pompeo, MsC         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Marco Vaz, PhD Federal University of Rio Grande do Sul
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Responsible Party: Marco Aurélio Vaz, PhD, Principal Investigator, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03663595    
Other Study ID Numbers: UFRGS - 2.809.328
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul:
Patellofemoral pain
Etiology
Multiarticular rehabilitation
Local factors
Nonlocal factors
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases