Treatment Effects on Neuromuscular Properties on Young Women Symptomatic for Patellofemoral Pain Syndrome
Effects of Two Treatment Models on Neuromuscular Properties of Young Women Symptomatic for Patellofemoral Pain Syndrome: A Randomized Controlled Trial
1 other identifier
interventional
86
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedMarch 31, 2022
March 1, 2022
1.2 years
August 30, 2018
March 18, 2022
Conditions
Keywords
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)
EXPERIMENTALFemales symptomatic for PFPS. This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.
PFPS: Model 2 (knee, foot and ankle)
EXPERIMENTALFemales 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 group
NO INTERVENTIONHealthy females not submitted to intervention
Interventions
Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
Eligibility Criteria
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
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.
PMID: 36067687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Vaz, PhD
Federal University of Rio Grande do Sul
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