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

NCT ID: NCT04478422

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-09-30

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.

Conditions

Patellofemoral Pain Syndrome; Vascular Occlusion

Keywords

Patellofemoral Pain Syndrome; Partial Vascular Occlusion; Postural Balance; Electromyography; Physical Therapy.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Muscle strengthening with vascular occlusion

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Conventional muscle strengthening

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Christiane Macedo

OTHER

Sponsor Role: lead

Responsible Party

Christiane Macedo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

State University of Londrina

Londrina, Paraná, Brazil

Countries

Brazil

References

Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.

Reference Type: BACKGROUND

PMID: 27749358 (View on PubMed)

Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.

Reference Type: BACKGROUND

PMID: 26971109 (View on PubMed)

Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.

Reference Type: BACKGROUND

PMID: 29266093 (View on PubMed)

Giles LS, Webster KE, McClelland JA, Cook J. Does quadriceps atrophy exist in individuals with patellofemoral pain? A systematic literature review with meta-analysis. J Orthop Sports Phys Ther. 2013 Nov;43(11):766-76. doi: 10.2519/jospt.2013.4833. Epub 2013 Sep 9.

Reference Type: BACKGROUND

PMID: 24175596 (View on PubMed)

Thijs KM, Zwerver J, Backx FJ, Steeneken V, Rayer S, Groenenboom P, Moen MH. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study. Clin J Sport Med. 2017 Mar;27(2):89-96. doi: 10.1097/JSM.0000000000000332.

Reference Type: BACKGROUND

PMID: 27347857 (View on PubMed)

Other Identifiers

Vascular Occlusion in PFPS

Identifier Type: -

Identifier Source: org_study_id