<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/NCT02984254</url>
  </required_header>
  <id_info>
    <org_study_id>15016/16</org_study_id>
    <nct_id>NCT02984254</nct_id>
  </id_info>
  <brief_title>Bracing for Patellofemoral Osteoarthritis</brief_title>
  <official_title>Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has&#xD;
      received relatively little attention in the OA literature and there are few treatment options&#xD;
      for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic&#xD;
      progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to&#xD;
      cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of&#xD;
      the patella disorder using strategies such as bracing or adhesive bandages can handle the&#xD;
      symptoms and progression of OA.&#xD;
&#xD;
      OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint&#xD;
      compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.&#xD;
&#xD;
      METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of:&#xD;
      overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will&#xD;
      be divided into two groups according to the knee brace that will receive: Functional Bracing&#xD;
      patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups&#xD;
      will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked&#xD;
      to do daily exercises in addition to reporting the daily consumption of drugs a month before&#xD;
      placing the orthotics up to three months after placing it. They will be evaluated with the&#xD;
      questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test,&#xD;
      Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to&#xD;
      placement of the brace, with one, three and after 12 months bracing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients that sign the informed consent will be randomized and asked to participate in a&#xD;
      4-hour course about knee osteoarthritis. They will be sent home with a form to fill in all&#xD;
      medications consumed daily for a month. They will return to the hospital where according to&#xD;
      data given by www.randomization.com, they will receive one of two braces in one or both knees&#xD;
      depending on their symptoms.&#xD;
&#xD;
      The functional brace has medial, lateral, superior and inferior &quot;ruber bands&quot; that should&#xD;
      center patella in the patella groove. The other traditional neoprene sleeve brace with a&#xD;
      patellar opening also tries to do the same with no other reinforcement other than the&#xD;
      neoprene sleeve.&#xD;
&#xD;
      Prior to bracing, patients will deliver the prior month medication form, answer WOMAC and&#xD;
      Lequesne questionnaires, and perform TUG, FTSST and the six-minute walk test.&#xD;
&#xD;
      They will be instructed to use the brace for 2 hours in the first day increasing half an hour&#xD;
      per day up to a maximum of 12 hours/day. In case of difficulties with the brace for 12&#xD;
      continuous hours, they will be allowed to use it for at least 4 hours with a 2 hours interval&#xD;
      and then again returning to bracing. Patients should sleep/rest without the brace(s). They&#xD;
      should use their braces during physical activities unless if under water.&#xD;
&#xD;
      The primary objective is to evaluate and compare the short-term benefits of knee&#xD;
      stabilization and compression. Therefore, the follow-up assessments, will be made prior to&#xD;
      bracing and after one and three months. The evaluation will include the delivery of the&#xD;
      registration of medications consumed daily (along with the hours of use of the orthosis), the&#xD;
      WOMAC and Lequesne questionnaires and functional evaluations. X-rays without the braces&#xD;
      (Front Schuss, profile and Axial) for measurement of affected joint spaces will be made&#xD;
      before inclusion and after one year. Panoramic X-rays of the lower limbs will be performed&#xD;
      before inclusion to measure the internal and external femoral-tibial angle. Complaints (pain,&#xD;
      slip, swelling, skin lesions) and satisfaction (decrease pain, mobility improvement) with the&#xD;
      use of the brace will be sought at each encounter. Patients will be asked about their weekly&#xD;
      physical activity (intensity, type and hours of physical activity) on any adverse effects&#xD;
      when using orthotics. Weight and height will be measured and each assessment to calculate&#xD;
      BMI.&#xD;
&#xD;
      The secondary objective is the improvement in pain, stiffness and long-term function (1&#xD;
      year). Therefore, after a brief analysis of the results of three months, if there is a&#xD;
      clinically significant difference between the groups, all patients will use the brace with&#xD;
      best results. Therefore the study will be a case series. If both groups show clinically&#xD;
      relevant improvements with no significant differences between the orthotics, the study will&#xD;
      remain with two arms and the same clinical assessments, questionnaires, functional and&#xD;
      radiographic one year. If none of the groups show a clinically relevant improvement in three&#xD;
      months, the study will be terminated. Adverse effects of the use of orthotics will also be&#xD;
      recorded in the one-year visit. All patients will be advised to discontinue use of the braces&#xD;
      and telephone to our secretary in case of any adverse effects in the period between the&#xD;
      official evaluations for proper conduct.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate improvement in function</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Apply the Lequesne questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in pain</measure>
    <time_frame>baseline, 1 month, 3 months and 1 year</time_frame>
    <description>Apply the WOMAC questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in stiffness</measure>
    <time_frame>baseline, 1 month, 3 months and 1 year</time_frame>
    <description>Apply the WOMAC questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in function with the TUG (Timed-Up-and-Go)</measure>
    <time_frame>baseline, 1 month, 3 months and 1 year</time_frame>
    <description>Apply TUG (Time-up-Go test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)</measure>
    <time_frame>baseline, 1 month, 3 months and 1 year</time_frame>
    <description>Apply Five-Times-Sit-To-Stand-Test (FTSST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in function with six minute walk test</measure>
    <time_frame>baseline, 1 month, 3 months and 1 year</time_frame>
    <description>Apply six minute walk test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Metabolic Disease</condition>
  <arm_group>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 Patients will use a a functional patellofemoral neoprene brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 Patients will use a neoprene sleeve brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Womac</intervention_name>
    <description>Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lequesne</intervention_name>
    <description>Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Timed-up-and-go (TUG)</intervention_name>
    <description>Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>five-times-sit-to-stand-test (FTSST)</intervention_name>
    <description>Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Six-minute walk test.</intervention_name>
    <description>Perform six-minute walk test at baseline, 3 months and 1 year</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>functional patellofemoral neoprene brace</intervention_name>
    <description>Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum</description>
    <arm_group_label>functional patellofemoral neoprene brace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>neoprene sleeve brace.</intervention_name>
    <description>Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum</description>
    <arm_group_label>neoprene sleeve brace.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic knee OA (patellofemoral)&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  Not using the brace as requested;&#xD;
&#xD;
          -  Study abandonment;&#xD;
&#xD;
          -  No adaptation to brace;&#xD;
&#xD;
          -  Skin and vascular complications by use of the brace;&#xD;
&#xD;
          -  Failure to complete the consumption of drugs between inclusion and bracing;&#xD;
&#xD;
          -  Obesity class II, III or morbid;&#xD;
&#xD;
          -  Patients who cannot read or understand the informed consent or the WOMAC&#xD;
             questionnaire;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcia U Rezende, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo</affiliation>
  </overall_official>
  <link>
    <url>https://www.omicsonline.org/peer-reviewed/parqveproject-arthritis-recovering-quality-of-life-by-means-of-education-shortterm-outcome-in-a-randomized-clinical-trial-20432.html</url>
    <description>PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial</description>
  </link>
  <link>
    <url>http://file.scirp.org/pdf/OJO_2016022614241788.pdf</url>
    <description>. Analysis of anthropometric measures and dietary intake in patients undergoing a multi-professional osteoarthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of Education</description>
  </link>
  <link>
    <url>http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0482-50042006000400004</url>
    <description>Translation and cultural validation of the Lequesne's algofunctional questionnaire for osteoarthritis of knee and hip for portuguese language</description>
  </link>
  <reference>
    <citation>Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.</citation>
    <PMID>17013996</PMID>
  </reference>
  <reference>
    <citation>McAlindon T, Zhang Y, Hannan M, Naimark A, Weissman B, Castelli W, Felson D. Are risk factors for patellofemoral and tibiofemoral knee osteoarthritis different? J Rheumatol. 1996 Feb;23(2):332-7.</citation>
    <PMID>8882042</PMID>
  </reference>
  <reference>
    <citation>Hunter DJ, Zhang YQ, Niu JB, Felson DT, Kwoh K, Newman A, Kritchevsky S, Harris T, Carbone L, Nevitt M. Patella malalignment, pain and patellofemoral progression: the Health ABC Study. Osteoarthritis Cartilage. 2007 Oct;15(10):1120-7. doi: 10.1016/j.joca.2007.03.020. Epub 2007 May 14.</citation>
    <PMID>17502158</PMID>
  </reference>
  <reference>
    <citation>Kalichman L, Zhang Y, Niu J, Goggins J, Gale D, Felson DT, Hunter D. The association between patellar alignment and patellofemoral joint osteoarthritis features--an MRI study. Rheumatology (Oxford). 2007 Aug;46(8):1303-8. doi: 10.1093/rheumatology/kem095. Epub 2007 May 24.</citation>
    <PMID>17525117</PMID>
  </reference>
  <reference>
    <citation>Hinman RS, Bennell KL, Crossley KM, McConnell J. Immediate effects of adhesive tape on pain and disability in individuals with knee osteoarthritis. Rheumatology (Oxford). 2003 Jul;42(7):865-9. doi: 10.1093/rheumatology/keg233. Epub 2003 Mar 31.</citation>
    <PMID>12730546</PMID>
  </reference>
  <reference>
    <citation>Hinman RS, Crossley KM, McConnell J, Bennell KL. Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomised controlled trial. BMJ. 2003 Jul 19;327(7407):135. doi: 10.1136/bmj.327.7407.135.</citation>
    <PMID>12869456</PMID>
  </reference>
  <reference>
    <citation>Cushnaghan J, McCarthy C, Dieppe P. Taping the patella medially: a new treatment for osteoarthritis of the knee joint? BMJ. 1994 Mar 19;308(6931):753-5. doi: 10.1136/bmj.308.6931.753.</citation>
    <PMID>8142829</PMID>
  </reference>
  <reference>
    <citation>Crossley KM, Marino GP, Macilquham MD, Schache AG, Hinman RS. Can patellar tape reduce the patellar malalignment and pain associated with patellofemoral osteoarthritis? Arthritis Rheum. 2009 Dec 15;61(12):1719-25. doi: 10.1002/art.24872.</citation>
    <PMID>19950307</PMID>
  </reference>
  <reference>
    <citation>McWalter EJ, Hunter DJ, Harvey WF, McCree P, Hirko KA, Felson DT, Wilson DR. The effect of a patellar brace on three-dimensional patellar kinematics in patients with lateral patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):801-8. doi: 10.1016/j.joca.2011.03.003. Epub 2011 Mar 11.</citation>
    <PMID>21397707</PMID>
  </reference>
  <reference>
    <citation>Hunter DJ, Harvey W, Gross KD, Felson D, McCree P, Li L, Hirko K, Zhang B, Bennell K. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):792-800. doi: 10.1016/j.joca.2010.12.010. Epub 2011 Jan 11.</citation>
    <PMID>21232620</PMID>
  </reference>
  <reference>
    <citation>Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.</citation>
    <PMID>3741515</PMID>
  </reference>
  <reference>
    <citation>KELLGREN JH, LAWRENCE JS. Radiological assessment of rheumatoid arthritis. Ann Rheum Dis. 1957 Dec;16(4):485-93. doi: 10.1136/ard.16.4.485. No abstract available.</citation>
    <PMID>13498603</PMID>
  </reference>
  <reference>
    <citation>McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM. Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1207-12. doi: 10.1093/gerona/59.11.1207.</citation>
    <PMID>15602077</PMID>
  </reference>
  <reference>
    <citation>Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.</citation>
    <PMID>17079748</PMID>
  </reference>
  <reference>
    <citation>de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.</citation>
    <PMID>23100188</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Marcia Uchoa Rezende</investigator_full_name>
    <investigator_title>MD; PhD</investigator_title>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>knee osteoarthritis</keyword>
  <keyword>Bracing</keyword>
  <keyword>patellofemoral osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02984254
org study id: 15016/16
nct id: NCT02984254
lead sponsor: 
has dmc: No
BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has
      received relatively little attention in the OA literature and there are few treatment options
      for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic
      progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to
      cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of
      the patella disorder using strategies such as bracing or adhesive bandages can handle the
      symptoms and progression of OA.

      OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint
      compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.

      METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of:
      overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will
      be divided into two groups according to the knee brace that will receive: Functional Bracing
      patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups
      will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked
      to do daily exercises in addition to reporting the daily consumption of drugs a month before
      placing the orthotics up to three months after placing it. They will be evaluated with the
      questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test,
      Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to
      placement of the brace, with one, three and after 12 months bracing.
All patients that sign the informed consent will be randomized and asked to participate in a
      4-hour course about knee osteoarthritis. They will be sent home with a form to fill in all
      medications consumed daily for a month. They will return to the hospital where according to
      data given by www.randomization.com, they will receive one of two braces in one or both knees
      depending on their symptoms.

      The functional brace has medial, lateral, superior and inferior "ruber bands" that should
      center patella in the patella groove. The other traditional neoprene sleeve brace with a
      patellar opening also tries to do the same with no other reinforcement other than the
      neoprene sleeve.

      Prior to bracing, patients will deliver the prior month medication form, answer WOMAC and
      Lequesne questionnaires, and perform TUG, FTSST and the six-minute walk test.

      They will be instructed to use the brace for 2 hours in the first day increasing half an hour
      per day up to a maximum of 12 hours/day. In case of difficulties with the brace for 12
      continuous hours, they will be allowed to use it for at least 4 hours with a 2 hours interval
      and then again returning to bracing. Patients should sleep/rest without the brace(s). They
      should use their braces during physical activities unless if under water.

      The primary objective is to evaluate and compare the short-term benefits of knee
      stabilization and compression. Therefore, the follow-up assessments, will be made prior to
      bracing and after one and three months. The evaluation will include the delivery of the
      registration of medications consumed daily (along with the hours of use of the orthosis), the
      WOMAC and Lequesne questionnaires and functional evaluations. X-rays without the braces
      (Front Schuss, profile and Axial) for measurement of affected joint spaces will be made
      before inclusion and after one year. Panoramic X-rays of the lower limbs will be performed
      before inclusion to measure the internal and external femoral-tibial angle. Complaints (pain,
      slip, swelling, skin lesions) and satisfaction (decrease pain, mobility improvement) with the
      use of the brace will be sought at each encounter. Patients will be asked about their weekly
      physical activity (intensity, type and hours of physical activity) on any adverse effects
      when using orthotics. Weight and height will be measured and each assessment to calculate
      BMI.

      The secondary objective is the improvement in pain, stiffness and long-term function (1
      year). Therefore, after a brief analysis of the results of three months, if there is a
      clinically significant difference between the groups, all patients will use the brace with
      best results. Therefore the study will be a case series. If both groups show clinically
      relevant improvements with no significant differences between the orthotics, the study will
      remain with two arms and the same clinical assessments, questionnaires, functional and
      radiographic one year. If none of the groups show a clinically relevant improvement in three
      months, the study will be terminated. Adverse effects of the use of orthotics will also be
      recorded in the one-year visit. All patients will be advised to discontinue use of the braces
      and telephone to our secretary in case of any adverse effects in the period between the
      official evaluations for proper conduct.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate improvement in function
time frame: baseline and 3 months
description: Apply the Lequesne questionnaire
measure: Improvement in pain
time frame: baseline, 1 month, 3 months and 1 year
description: Apply the WOMAC questionnaire
measure: Improvement in stiffness
time frame: baseline, 1 month, 3 months and 1 year
description: Apply the WOMAC questionnaire
measure: Improvement in function with the TUG (Timed-Up-and-Go)
time frame: baseline, 1 month, 3 months and 1 year
description: Apply TUG (Time-up-Go test)
measure: Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
time frame: baseline, 1 month, 3 months and 1 year
description: Apply Five-Times-Sit-To-Stand-Test (FTSST)
measure: Improvement in function with six minute walk test
time frame: baseline, 1 month, 3 months and 1 year
description: Apply six minute walk test
arm group label: functional patellofemoral neoprene brace
arm group type: Experimental
description: 26 Patients will use a a functional patellofemoral neoprene brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
arm group label: neoprene sleeve brace.
arm group type: Experimental
description: 26 Patients will use a neoprene sleeve brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
intervention type: Device
intervention name: Womac
description: Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
arm group label: functional patellofemoral neoprene brace
arm group label: neoprene sleeve brace.
intervention type: Device
intervention name: Lequesne
description: Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
arm group label: functional patellofemoral neoprene brace
arm group label: neoprene sleeve brace.
intervention type: Device
intervention name: Timed-up-and-go (TUG)
description: Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
arm group label: functional patellofemoral neoprene brace
arm group label: neoprene sleeve brace.
intervention type: Device
intervention name: five-times-sit-to-stand-test (FTSST)
description: Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year
arm group label: functional patellofemoral neoprene brace
arm group label: neoprene sleeve brace.
intervention type: Device
intervention name: Six-minute walk test.
description: Perform six-minute walk test at baseline, 3 months and 1 year
arm group label: functional patellofemoral neoprene brace
arm group label: neoprene sleeve brace.
intervention type: Device
intervention name: functional patellofemoral neoprene brace
description: Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum
arm group label: functional patellofemoral neoprene brace
intervention type: Device
intervention name: neoprene sleeve brace.
description: Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum
arm group label: neoprene sleeve brace.
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marcia U Rezende, MD; PhD
role: Principal Investigator
affiliation: Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
url: https://www.omicsonline.org/peer-reviewed/parqveproject-arthritis-recovering-quality-of-life-by-means-of-education-shortterm-outcome-in-a-randomized-clinical-trial-20432.html
description: PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial
url: http://file.scirp.org/pdf/OJO_2016022614241788.pdf
description: . Analysis of anthropometric measures and dietary intake in patients undergoing a multi-professional osteoarthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of Education
url: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0482-50042006000400004
description: Translation and cultural validation of the Lequesne's algofunctional questionnaire for osteoarthritis of knee and hip for portuguese language
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PMID: 17525117
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PMID: 12730546
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PMID: 12869456
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PMID: 21397707
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PMID: 21232620
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citation: de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.
PMID: 23100188
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Marcia Uchoa Rezende
investigator title: MD; PhD
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Metabolic Diseases
sharing ipd: Undecided