Muscle Training With and Without Vascular Occlusion of Women With Patellofemoral Pain Syndrome: A Random Clinical Trial

Study Overview
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Brief Summary
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Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the quadriceps muscle to increase muscle strength and endurance, without joint overload or discomfort to the patient. However, there is no consensus on the use in individuals with PFPS. Objective: To establish the effect of quadriceps muscle strengthening with OVP and low resistance to exercise on pain, functionality, postural control and muscle recruitment in women with patellofemoral dysfunction. Methods: Women with PFPS (n = 20) will respond to pain and functionality scales. The postural control and muscle recruitment of the quadriceps will also be evaluated in dynamic activities of single-legged squat and up / down stairs using a force platform and surface electromyography. After the initial assessment, the participants will be randomized into two groups: conventional quadriceps strengthening with greater resistance loads to exercise and quadriceps strengthening with OVP and low loads. And they will perform a six-week treatment protocol with exercises to strengthen the quadriceps. At the end of the intervention protocols, all of them will be reassessed immediately, after four and eight weeks. Expected Results: It is expected that the group submitted to exercises with OVP and lower load will present the same results of postural control and muscle recruitment compared to the conventional strengthening group. These results will indicate the possibility of using exercises and loads with less joint impairment.

Official Title
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Effects of a Muscle Training Program With and Without Vascular Occlusion in Pain, Functionality, Postural Control and Muscular Recruitment of Women With Patellophemoral Pain Syndrome: A Random Clinical Trial

Conditions
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Patellofemoral Pain Syndrome, Vascular Occlusion

Intervention / Treatment
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* Other: Muscle strengthening with vascular occlusion
* Other: Conventional muscle strengthening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insidious onset of symptoms unrelated to trauma, pain for at least three months; pain greater than three (3/10) in at least three of the functional activities (squatting for a long time, going up or down stairs, kneeling, running, remaining in a sitting position for a long time), maximum 86 points on the Anterior Knee Pain Scale (AKPS). Exclusion Criteria: Signs and symptoms of other coexisting knee pathologies (arthrosis, prostheses, meniscal and ligament injuries), pain in other joints of the lower limb; lumbar spine pain, neurological, rheumatological, vascular and metabolic diseases; pregnancy; history of lower limb surgery; corticosteroid injection in the knee applied in the last three months, physiotherapy for knee rehabilitation in the last six months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle strengthening with vascular occlusion<br>Quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, with partial occlusion to blood flow. The occlusion equipment will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). | Other: Muscle strengthening with vascular occlusion<br>* The muscle strengthening group with partial vascular occlusion will perform the strengthening exercises: single leg squat on 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat. The equipment for vascular occlusion will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). If necessary, the pressure can be adjusted at intervals and after the end of the exercise, an interval of 5 minutes is suggested for blood reperfusion.<br>|
| Active Comparator: Conventional muscle strengthening<br>Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow. | Other: Conventional muscle strengthening<br>* The conventional muscle strengthening group perform the same exercises as the intervention group: One-legged squat on a 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat, however, without restriction on blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain in the knee by scale score | Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain. | pre-intervention, immediately after, after four weeks | 
| Change in functional capacity by scale score | Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functional capacity. | pre-intervention, immediately after, after four weeks | 
| Change in functional capacity by scale score | Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functional capacity. | pre-intervention, immediately after, after four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle activition by electromyography variables | Muscle activition by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs. | pre-intervention, immediately after, after four weeks | 
| Change in quadriceps muscle strength | Change in quadriceps muscle strength by portable dynamometry | pre-intervention, immediately after, after four weeks | 
| Change in Postural control by pressure center variables | Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs. | pre-intervention, immediately after, after four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patellofemoral Pain Syndrome, Partial Vascular Occlusion, Postural Balance, Electromyography, Physical Therapy.