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Completed

NCT Number: NCT03663595

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

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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Model 1

Other

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

Other names: Local and proximal factors

Model 2

Other

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

Other names: Local and distal factors

Primary outcomes

  1. Change of knee pain

    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 Numeric Pain Rating Scale (0 to 10)

  2. Self-reported functionality

    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.

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

  3. Change in knee muscles, hip muscles, ankle muscles and foot muscles strength

    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

  4. 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 alignement

  5. 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.

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

  6. 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) will be assessed by ultrasonography

  7. Muscle 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.

    Muscle activation will be assessed by electromyography

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

Effects of Two Treatment Models on Neuromuscular Properties of Young Women Symptomatic for Patellofemoral Pain Syndrome: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Sep 10, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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