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NCT Number: NCT04478422

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

State University of Londrina

Londrina, Paraná, 86041-263, Brazil

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Muscle strengthening with vascular occlusion

Other

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.

Conventional muscle strengthening

Other

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.

Primary outcomes

  1. Change in Pain in the knee by scale score

    Time frame: pre-intervention, immediately after, after four weeks

    Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.

  2. Change in functional capacity by scale score

    Time frame: pre-intervention, immediately after, after four weeks

    Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functional capacity.

  3. Change in functional capacity by scale score

    Time frame: pre-intervention, immediately after, after four weeks

    Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functional capacity.

Secondary outcomes

  1. Change in Muscle activition by electromyography variables

    Time frame: pre-intervention, immediately after, after four weeks

    Muscle activition by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.

  2. Change in quadriceps muscle strength

    Time frame: pre-intervention, immediately after, after four weeks

    Change in quadriceps muscle strength by portable dynamometry

  3. Change in Postural control by pressure center variables

    Time frame: pre-intervention, immediately after, after four weeks

    Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.

Sponsors and collaborators

Lead sponsor

Christiane Macedo

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jul 20, 2020
Registry last updated
Dec 12, 2023

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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