<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478422</url>
  </required_header>
  <id_info>
    <org_study_id>Vascular Occlusion in PFPS</org_study_id>
    <nct_id>NCT04478422</nct_id>
  </id_info>
  <brief_title>Muscle Training With and Without Vascular Occlusion of Women With Patellofemoral Pain Syndrome: A Random Clinical Trial</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christiane Macedo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual de Londrina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of&#xD;
      the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the&#xD;
      quadriceps muscle to increase muscle strength and endurance, without joint overload or&#xD;
      discomfort to the patient. However, there is no consensus on the use in individuals with&#xD;
      PFPS. Objective: To establish the effect of quadriceps muscle strengthening with OVP and low&#xD;
      resistance to exercise on pain, functionality, postural control and muscle recruitment in&#xD;
      women with patellofemoral dysfunction. Methods: Women with PFPS (n = 20) will respond to pain&#xD;
      and functionality scales. The postural control and muscle recruitment of the quadriceps will&#xD;
      also be evaluated in dynamic activities of single-legged squat and up / down stairs using a&#xD;
      force platform and surface electromyography. After the initial assessment, the participants&#xD;
      will be randomized into two groups: conventional quadriceps strengthening with greater&#xD;
      resistance loads to exercise and quadriceps strengthening with OVP and low loads. And they&#xD;
      will perform a six-week treatment protocol with exercises to strengthen the quadriceps. At&#xD;
      the end of the intervention protocols, all of them will be reassessed immediately, after four&#xD;
      and eight weeks. Expected Results: It is expected that the group submitted to exercises with&#xD;
      OVP and lower load will present the same results of postural control and muscle recruitment&#xD;
      compared to the conventional strengthening group. These results will indicate the possibility&#xD;
      of using exercises and loads with less joint impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Muscle recruitment by electromyography variables</measure>
    <time_frame>pre-intervention, immediately after, after four and eight weeks</time_frame>
    <description>Muscle recruitment by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in functionality by scale score</measure>
    <time_frame>pre-intervention, immediately after, after four and eight weeks</time_frame>
    <description>Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functionality by scale score</measure>
    <time_frame>pre-intervention, immediately after, after four and eight weeks</time_frame>
    <description>Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functionality.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Postural control by pressure center variables</measure>
    <time_frame>pre-intervention, immediately after, after four and eight weeks</time_frame>
    <description>Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Pain in the knee by scale score</measure>
    <time_frame>pre-intervention, immediately after, after four and eight weeks</time_frame>
    <description>Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <condition>Vascular Occlusion</condition>
  <arm_group>
    <arm_group_label>Muscle strengthening with vascular occlusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional muscle strengthening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle strengthening with vascular occlusion</intervention_name>
    <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.</description>
    <arm_group_label>Muscle strengthening with vascular occlusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional muscle strengthening</intervention_name>
    <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.</description>
    <arm_group_label>Conventional muscle strengthening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Feminine gender;&#xD;
&#xD;
          -  Age between 18 and 40 years;&#xD;
&#xD;
          -  Clinical diagnosis of patellofemoral dysfunction by an orthopedist knee specialist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute knee or patellar tendon injury, chronic inflammatory joint diseases (rheumatoid&#xD;
             arthritis) or signs and symptoms of other knee pathologies (coexisting),&#xD;
&#xD;
          -  Use of immunosuppressive medication or corticosteroids in the last six months;&#xD;
&#xD;
          -  Anterior knee surgery (anterior cruciate ligament, meniscus or in the patellar&#xD;
             tendon);&#xD;
&#xD;
          -  Local injection (corticosteroid) of the knee in the previous month. (Thijs et al.&#xD;
             2017).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christiane Macedo, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of Londrina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daiene Ferreira, Master</last_name>
    <phone>+55 43 999376175</phone>
    <email>daiene_ferreira@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christiane Macedo, Doctor</last_name>
    <phone>+55 43 991015123</phone>
    <email>chmacedouel@yahoo.com.br</email>
  </overall_contact_backup>
  <reference>
    <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.</citation>
    <PMID>27749358</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26971109</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29266093</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24175596</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27347857</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual de Londrina</investigator_affiliation>
    <investigator_full_name>Christiane Macedo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Patellofemoral Pain Syndrome</keyword>
  <keyword>Partial Vascular Occlusion</keyword>
  <keyword>Postural Balance</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Physical Therapy.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478422
org study id: Vascular Occlusion in PFPS
nct id: NCT04478422
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Muscle recruitment by electromyography variables
time frame: pre-intervention, immediately after, after four and eight weeks
description: Muscle recruitment by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.
measure: Change in functionality by scale score
time frame: pre-intervention, immediately after, after four and eight weeks
description: Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functionality.
measure: Change in functionality by scale score
time frame: pre-intervention, immediately after, after four and eight weeks
description: Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functionality.
measure: Change in Postural control by pressure center variables
time frame: pre-intervention, immediately after, after four and eight weeks
description: Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.
measure: Change in Pain in the knee by scale score
time frame: pre-intervention, immediately after, after four and eight weeks
description: Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.
arm group label: Muscle strengthening with vascular occlusion
arm group type: Experimental
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 group label: Conventional muscle strengthening
arm group type: Active Comparator
description: Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow.
intervention type: Other
intervention name: Muscle strengthening with vascular occlusion
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.
arm group label: Muscle strengthening with vascular occlusion
intervention type: Other
intervention name: Conventional muscle strengthening
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.
arm group label: Conventional muscle strengthening
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Christiane Macedo, Doctor
role: Principal Investigator
affiliation: State University of Londrina
last name: Daiene Ferreira, Master
phone: +55 43 999376175
email: daiene_ferreira@hotmail.com
last name: Christiane Macedo, Doctor
phone: +55 43 991015123
email: chmacedouel@yahoo.com.br
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.
PMID: 27749358
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.
PMID: 26971109
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.
PMID: 29266093
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.
PMID: 24175596
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.
PMID: 27347857
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Estadual de Londrina
investigator full name: Christiane Macedo
investigator title: Principal Investigator
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No