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

Primary Purpose

Patellofemoral Pain Syndrome, Vascular Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle strengthening with vascular occlusion
Conventional muscle strengthening
Sponsored by
Christiane Macedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral Pain Syndrome, Partial Vascular Occlusion, Postural Balance, Electromyography, Physical Therapy.

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Muscle strengthening with vascular occlusion

    Conventional muscle strengthening

    Arm Description

    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).

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

    Outcomes

    Primary Outcome Measures

    Change in Muscle recruitment by electromyography variables
    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
    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
    Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functionality.

    Full Information

    First Posted
    July 10, 2020
    Last Updated
    July 15, 2020
    Sponsor
    Christiane Macedo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04478422
    Brief Title
    Muscle Training With and Without Vascular Occlusion of Women With Patellofemoral Pain Syndrome: A Random Clinical Trial
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Christiane Macedo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellofemoral Pain Syndrome, Vascular Occlusion
    Keywords
    Patellofemoral Pain Syndrome, Partial Vascular Occlusion, Postural Balance, Electromyography, Physical Therapy.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Muscle strengthening with vascular occlusion
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Conventional muscle strengthening
    Arm Type
    Active Comparator
    Arm Description
    Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow.
    Intervention Type
    Other
    Intervention Name(s)
    Muscle strengthening with vascular occlusion
    Intervention Description
    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
    Intervention Name(s)
    Conventional muscle strengthening
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in Muscle recruitment by electromyography variables
    Description
    Muscle recruitment by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.
    Time Frame
    pre-intervention, immediately after, after four and eight weeks
    Secondary Outcome Measure Information:
    Title
    Change in functionality by scale score
    Description
    Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functionality.
    Time Frame
    pre-intervention, immediately after, after four and eight weeks
    Title
    Change in functionality by scale score
    Description
    Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functionality.
    Time Frame
    pre-intervention, immediately after, after four and eight weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in Postural control by pressure center variables
    Description
    Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.
    Time Frame
    pre-intervention, immediately after, after four and eight weeks
    Title
    Change in Pain in the knee by scale score
    Description
    Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.
    Time Frame
    pre-intervention, immediately after, after four and eight weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daiene Ferreira, Master
    Phone
    +55 43 999376175
    Email
    daiene_ferreira@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christiane Macedo, Doctor
    Phone
    +55 43 991015123
    Email
    chmacedouel@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christiane Macedo, Doctor
    Organizational Affiliation
    State University of Londrina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27749358
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26971109
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29266093
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24175596
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27347857
    Citation
    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.
    Results Reference
    background

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

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