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

Sponsor

Christiane Macedo (Other)

Overall Status

Unknown status

CT.gov ID

NCT04478422

Collaborator

(none)

Enrollment

Arms

6.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Pain Syndrome Vascular Occlusion	Other: Muscle strengthening with vascular occlusion Other: Conventional muscle strengthening	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Muscle strengthening with vascular occlusion 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 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.
Active Comparator: Conventional muscle strengthening Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow.	Other: Conventional muscle strengthening 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.

Arm

Intervention/Treatment

Experimental: Muscle strengthening with vascular occlusion

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

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.

Active Comparator: Conventional muscle strengthening

Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow.

Other: Conventional muscle strengthening

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.

Outcome Measures

Primary Outcome Measures

Change in Muscle recruitment by electromyography variables [pre-intervention, immediately after, after four and eight weeks]
Muscle recruitment by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.

Secondary Outcome Measures

Change in functionality by scale score [pre-intervention, immediately after, after four and eight weeks]
Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functionality.
Change in functionality by scale score [pre-intervention, immediately after, after four and eight weeks]
Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functionality.

Other Outcome Measures

Change in Postural control by pressure center variables [pre-intervention, immediately after, after four and eight weeks]
Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.
Change in Pain in the knee by scale score [pre-intervention, immediately after, after four and eight weeks]
Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Feminine gender;
Age between 18 and 40 years;
Clinical diagnosis of patellofemoral dysfunction by an orthopedist knee specialist.

Exclusion Criteria:

Acute knee or patellar tendon injury, chronic inflammatory joint diseases (rheumatoid arthritis) or signs and symptoms of other knee pathologies (coexisting),
Use of immunosuppressive medication or corticosteroids in the last six months;
Anterior knee surgery (anterior cruciate ligament, meniscus or in the patellar tendon);
Local injection (corticosteroid) of the knee in the previous month. (Thijs et al. 2017).