<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/NCT02241148</url>
  </required_header>
  <id_info>
    <org_study_id>OR14-003</org_study_id>
    <secondary_id>OR14-003</secondary_id>
    <secondary_id>OR14-003</secondary_id>
    <secondary_id>OR14-003</secondary_id>
    <nct_id>NCT02241148</nct_id>
  </id_info>
  <brief_title>Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome</brief_title>
  <official_title>Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Nuevo Leon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Nuevo Leon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will include patients attending outpatient clinic in the area of&#xD;
      Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral&#xD;
      Pain Syndrome.&#xD;
&#xD;
      Two groups would be made, the control group will receive treatment with acetaminophen and&#xD;
      physical therapy rehabilitation, closed chain exercises and stretches at home intended for&#xD;
      the strengthening of quadriceps, abductors and internal rotators of the hip for the duration&#xD;
      of six weeks. The experimental treatment group will receive the above plus the application of&#xD;
      the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both&#xD;
      groups will be evaluated by an external consultation. They will be assessed by the Tegner&#xD;
      Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain&#xD;
      assessment; these scales will be applied at the beginning, third and sixth week&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will include patients attending outpatient clinic in the area of&#xD;
      Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral&#xD;
      Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting&#xD;
      unilateral Patellofemoral pain syndrome with six months of evolution, presenting anterior or&#xD;
      retro knee pain that presents itself when undergoing two or more of the following activities:&#xD;
      squatting, running, kneeling, jumping, or climbing stairs; physically active patients, with&#xD;
      at least thirty minutes of physical activity at least three times per week. Exclusion&#xD;
      criteria include patients with previous knee surgeries, chronic pain with more than one year&#xD;
      of evolution, pregnancy or suspected pregnancy, application of intra-articular steroids in&#xD;
      the three months prior to their evaluation, patients with meniscal injuries, ligament or&#xD;
      intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid&#xD;
      arthritis, Osteoarthritis of the knee, hip or ankle, history of dislocation or subluxation of&#xD;
      patella, Osgood Schlatter syndrome and patellar tendinitis or quadriceps.&#xD;
&#xD;
      The investigators will divide patients into two groups. The control group will receive&#xD;
      treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and&#xD;
      stretches at home intended for the strengthening of quadriceps, abductors and internal&#xD;
      rotators of the hip for the duration of six weeks. The experimental treatment group will&#xD;
      receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ®&#xD;
      Kinesio taping on the affected knee. Both groups will be evaluated by an external&#xD;
      consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the&#xD;
      WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the&#xD;
      beginning, third and sixth week. The patients in the experimental group will be quoted each&#xD;
      week to change the tape. The control group will be quoted at the beginning, at three weeks&#xD;
      and after six weeks. During the first appointment we will take patients anthropometric&#xD;
      measurements (weight, height, BMI) as well as general information. Radiographic studies&#xD;
      (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out&#xD;
      other diseases and see the degree of contact of the patella on the patellofemoral joint. All&#xD;
      patients will receive an explanation about their illness, and a booklet with the required&#xD;
      exercises as well as their frequency.&#xD;
&#xD;
      For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that&#xD;
      were placed inferior to the head with no pressure applied, then two bands are placed at the&#xD;
      ends of the tape and crossed on the edges of the patella and ending at the thigh to finish&#xD;
      applying moderate tension to place them, then two strips were placed at each end of the edges&#xD;
      of the first and second tape without applying pressure. The tapes can last up to five days on&#xD;
      the extremities while maintaining their purpose, patients included in this group will be&#xD;
      summoned each week to remove the tapes and place new ones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Required number of participants were not able to be enrolled.&#xD;
  </why_stopped>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">August 17, 2017</completion_date>
  <primary_completion_date type="Actual">August 17, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Closed kinetic chain exercise with kinesio taping pain relief measured in the Kujala score</measure>
    <time_frame>Baseline,3 weeks, 6 weeks</time_frame>
    <description>The Kujala patellofemoral score is a functional evaluation instrument to evaluate knee problems related to the patellofemoral system.It is a 13-item knee-specific self-report questionnaire.&#xD;
It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Closed kinetic chain exercise with kinesio taping pain relief measured in the Tegner Activity Scale.</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
    <description>The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Closed kinetic chain exercise with kinesio taping pain relief measured in WOMAC</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.&#xD;
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties</description>
  </other_outcome>
  <other_outcome>
    <measure>Closed kinetic chain exercise with kinesio taping pain relief measured in the visual analog scale (VAS) for pain assessment.</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
    <description>The pain VAS is a unidimensional measure of pain intensity. For pain intensity, the scale is most commonly anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 10).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Acetaminophen 500mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesio taping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental treatment group will receive acetaminophen 500mg and physical therapy rehabilitation, plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen 500mg</intervention_name>
    <description>500 mg, tablets every 8 hours</description>
    <arm_group_label>Acetaminophen 500mg</arm_group_label>
    <other_name>Tempra® 500mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesio taping</intervention_name>
    <description>Taping will be changed every week.</description>
    <arm_group_label>Kinesio taping</arm_group_label>
    <other_name>SpiderTech ® Kinesio taping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age between fifteen and thirty-five years,&#xD;
&#xD;
          -  Presenting unilateral PFPS with six months of evolution,&#xD;
&#xD;
          -  Presenting anterior or retro knee pain that presents itself when undergoing two or&#xD;
             more of the following activities:&#xD;
&#xD;
        (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at&#xD;
        least thirty minutes of physical activity at least three times per week.)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with previous knee surgeries,&#xD;
&#xD;
          -  Chronic pain with more than one year of evolution,&#xD;
&#xD;
          -  Pregnancy or suspected pregnancy&#xD;
&#xD;
          -  Application of intra-articular steroids in the three months prior to their evaluation&#xD;
&#xD;
          -  Patients with meniscal injuries&#xD;
&#xD;
          -  Ligament or intra-articular knee structures&#xD;
&#xD;
          -  Degenerative diseases such as diabetes&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Osteoarthritis of the knee, hip or ankle&#xD;
&#xD;
          -  History of dislocation or subluxation of patella&#xD;
&#xD;
          -  Osgood Schlatter syndrome&#xD;
&#xD;
          -  Patellar tendinitis or quadriceps.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felix Vilchez, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Autonoma de Nuevo Leon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Facultad de Medicina UANL</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>66235</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Nuevo Leon</investigator_affiliation>
    <investigator_full_name>FELIX VILCHEZ CAVAZOS</investigator_full_name>
    <investigator_title>Dr. med. Felix Vilchez Cavazos</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02241148
org study id: OR14-003
secondary id: OR14-003
secondary id: OR14-003
secondary id: OR14-003
nct id: NCT02241148
lead sponsor: 
has dmc: No
The investigators will include patients attending outpatient clinic in the area of
      Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral
      Pain Syndrome.

      Two groups would be made, the control group will receive treatment with acetaminophen and
      physical therapy rehabilitation, closed chain exercises and stretches at home intended for
      the strengthening of quadriceps, abductors and internal rotators of the hip for the duration
      of six weeks. The experimental treatment group will receive the above plus the application of
      the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both
      groups will be evaluated by an external consultation. They will be assessed by the Tegner
      Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain
      assessment; these scales will be applied at the beginning, third and sixth week
The investigators will include patients attending outpatient clinic in the area of
      Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral
      Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting
      unilateral Patellofemoral pain syndrome with six months of evolution, presenting anterior or
      retro knee pain that presents itself when undergoing two or more of the following activities:
      squatting, running, kneeling, jumping, or climbing stairs; physically active patients, with
      at least thirty minutes of physical activity at least three times per week. Exclusion
      criteria include patients with previous knee surgeries, chronic pain with more than one year
      of evolution, pregnancy or suspected pregnancy, application of intra-articular steroids in
      the three months prior to their evaluation, patients with meniscal injuries, ligament or
      intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid
      arthritis, Osteoarthritis of the knee, hip or ankle, history of dislocation or subluxation of
      patella, Osgood Schlatter syndrome and patellar tendinitis or quadriceps.

      The investigators will divide patients into two groups. The control group will receive
      treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and
      stretches at home intended for the strengthening of quadriceps, abductors and internal
      rotators of the hip for the duration of six weeks. The experimental treatment group will
      receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ®
      Kinesio taping on the affected knee. Both groups will be evaluated by an external
      consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the
      WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the
      beginning, third and sixth week. The patients in the experimental group will be quoted each
      week to change the tape. The control group will be quoted at the beginning, at three weeks
      and after six weeks. During the first appointment we will take patients anthropometric
      measurements (weight, height, BMI) as well as general information. Radiographic studies
      (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out
      other diseases and see the degree of contact of the patella on the patellofemoral joint. All
      patients will receive an explanation about their illness, and a booklet with the required
      exercises as well as their frequency.

      For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that
      were placed inferior to the head with no pressure applied, then two bands are placed at the
      ends of the tape and crossed on the edges of the patella and ending at the thigh to finish
      applying moderate tension to place them, then two strips were placed at each end of the edges
      of the first and second tape without applying pressure. The tapes can last up to five days on
      the extremities while maintaining their purpose, patients included in this group will be
      summoned each week to remove the tapes and place new ones.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Closed kinetic chain exercise with kinesio taping pain relief measured in the Kujala score
time frame: Baseline,3 weeks, 6 weeks
description: The Kujala patellofemoral score is a functional evaluation instrument to evaluate knee problems related to the patellofemoral system.It is a 13-item knee-specific self-report questionnaire.
It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion.
measure: Closed kinetic chain exercise with kinesio taping pain relief measured in the Tegner Activity Scale.
time frame: Baseline, 3 weeks, 6 weeks
description: The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level
measure: Closed kinetic chain exercise with kinesio taping pain relief measured in WOMAC
time frame: Baseline, 3 weeks, 6 weeks
description: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties
measure: Closed kinetic chain exercise with kinesio taping pain relief measured in the visual analog scale (VAS) for pain assessment.
time frame: Baseline, 3 weeks, 6 weeks
description: The pain VAS is a unidimensional measure of pain intensity. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
arm group label: Acetaminophen 500mg
arm group type: Active Comparator
description: The control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation
arm group label: Kinesio taping
arm group type: Experimental
description: The experimental treatment group will receive acetaminophen 500mg and physical therapy rehabilitation, plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping
intervention type: Drug
intervention name: Acetaminophen 500mg
description: 500 mg, tablets every 8 hours
arm group label: Acetaminophen 500mg
other name: Tempra® 500mg
intervention type: Device
intervention name: Kinesio taping
description: Taping will be changed every week.
arm group label: Kinesio taping
other name: SpiderTech ® Kinesio taping
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Felix Vilchez, Dr. med.
role: Principal Investigator
affiliation: Universidad Autonoma de Nuevo Leon
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Nuevo Leon
investigator full name: FELIX VILCHEZ CAVAZOS
investigator title: Dr. med. Felix Vilchez Cavazos
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders
mesh term: Acetaminophen