<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/NCT03280524</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 30795814.8.0000.5102</org_study_id>
    <nct_id>NCT03280524</nct_id>
  </id_info>
  <brief_title>Reflexology and Quality of Life</brief_title>
  <official_title>Reflexology and Quality of Life in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Vale do Sapucai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Vale do Sapucai</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>
      This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients&#xD;
      divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The&#xD;
      TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the&#xD;
      CG will only receive the guideline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the effects of reflexology on the quality of life&#xD;
      and functional capacity of patients at risk for diabetic neuropathy. This is a randomized,&#xD;
      controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria&#xD;
      are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years,&#xD;
      both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes&#xD;
      Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered&#xD;
      the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive&#xD;
      abilities, and previous treatment using reflexology. For the calculation of the sample size,&#xD;
      a pilot test will be conducted with 8 diabetic patients. It will be used the statistical&#xD;
      software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of&#xD;
      30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care&#xD;
      guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the&#xD;
      guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36)&#xD;
      and for functional capacity, the Stanford Health Assessment Questionnaire. This research will&#xD;
      follow the standards set by resolution 466/12 of the National Health Council, for research&#xD;
      with human beings and will be conducted in accordance with the ethical recommendations of the&#xD;
      Declaration of Helsinki.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">March 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>
    <intervention_model_description>The patients will be taken to a room reserved for the procedure. First, the patients answer the research instruments and then they will be asked to lie supine on a stretcher. The feet of the patients will be cleaned with water (37ºC) and mild soap and then will be dry with paper towels. The next phase consists in the application of foot massage, that will follow the Lourenço's Protocol (2012), which consists of 14 steps of relaxation massage. Each step will have duration of 1 minute, 3 procedures by week, by 4 consecutive weeks. The research instruments, SF-36 and Stanford Health Assessment Questionnarie will be applied before the first and after the last procedure.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>To ensure the blinding, the study included an interventionist enabled for application of foot reflexology.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life Questionnaire SF-36</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>measure of quality of life</description>
  </primary_outcome>
  <other_outcome>
    <measure>Stanford Health Assessment Questionnaire</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>measure of functional capacity</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control Group will receive self-care guidelines with feet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reflexology</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>massage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-care guidelines with feet</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75&#xD;
             years, both sexes, and registered in the Primary Health Care Unit of São João or in&#xD;
             the Diabetes Education Center in Minas Gerais state, Brazil.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive&#xD;
             abilities, and previous treatment using reflexology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatriz Ms Martínez, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Vale do Sapucai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes Education Center</name>
      <address>
        <city>Pouso Alegre</city>
        <state>Minas Gerais</state>
        <zip>37550000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Aguiar CC, Vieira AP, Carvalho AF, Montenegro-Junior RM. [Assessment instruments for a Health-Related Quality of Life in diabetes mellitus]. Arq Bras Endocrinol Metabol. 2008 Aug;52(6):931-9. doi: 10.1590/s0004-27302008000600004. Portuguese.</citation>
    <PMID>18820804</PMID>
  </reference>
  <reference>
    <citation>Kaul K, Tarr JM, Ahmad SI, Kohner EM, Chibber R. Introduction to diabetes mellitus. Adv Exp Med Biol. 2012;771:1-11. doi: 10.1007/978-1-4614-5441-0_1.</citation>
    <PMID>23393665</PMID>
  </reference>
  <reference>
    <citation>Tiran D, Chummun H. The physiological basis of reflexology and its use as a potential diagnostic tool. Complement Ther Clin Pract. 2005 Feb;11(1):58-64. doi: 10.1016/j.ctnm.2004.07.007.</citation>
    <PMID>15984227</PMID>
  </reference>
  <reference>
    <citation>Armstrong AR, Thiebaut SP, Brown LJ, Nepal B. Australian adults use complementary and alternative medicine in the treatment of chronic illness: a national study. Aust N Z J Public Health. 2011 Aug;35(4):384-90. doi: 10.1111/j.1753-6405.2011.00745.x.</citation>
    <PMID>21806735</PMID>
  </reference>
  <reference>
    <citation>Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM. The efficacy of reflexology: systematic review. J Adv Nurs. 2008 Jun;62(5):512-20. doi: 10.1111/j.1365-2648.2008.04606.x.</citation>
    <PMID>18489444</PMID>
  </reference>
  <reference>
    <citation>Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.</citation>
    <PMID>1593914</PMID>
  </reference>
  <reference>
    <citation>Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.</citation>
    <PMID>5349366</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Vale do Sapucai</investigator_affiliation>
    <investigator_full_name>Beatriz Bertolaccini Martínez</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Reflexology,diabetes, quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</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/NCT03280524
org study id: CAAE: 30795814.8.0000.5102
nct id: NCT03280524
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients
      divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The
      TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the
      CG will only receive the guideline.
The purpose of this study is to evaluate the effects of reflexology on the quality of life
      and functional capacity of patients at risk for diabetic neuropathy. This is a randomized,
      controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria
      are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years,
      both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes
      Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered
      the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive
      abilities, and previous treatment using reflexology. For the calculation of the sample size,
      a pilot test will be conducted with 8 diabetic patients. It will be used the statistical
      software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of
      30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care
      guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the
      guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36)
      and for functional capacity, the Stanford Health Assessment Questionnaire. This research will
      follow the standards set by resolution 466/12 of the National Health Council, for research
      with human beings and will be conducted in accordance with the ethical recommendations of the
      Declaration of Helsinki.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients will be taken to a room reserved for the procedure. First, the patients answer the research instruments and then they will be asked to lie supine on a stretcher. The feet of the patients will be cleaned with water (37ºC) and mild soap and then will be dry with paper towels. The next phase consists in the application of foot massage, that will follow the Lourenço's Protocol (2012), which consists of 14 steps of relaxation massage. Each step will have duration of 1 minute, 3 procedures by week, by 4 consecutive weeks. The research instruments, SF-36 and Stanford Health Assessment Questionnarie will be applied before the first and after the last procedure.
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: To ensure the blinding, the study included an interventionist enabled for application of foot reflexology.
measure: Quality of Life Questionnaire SF-36
time frame: An average of 1 year
description: measure of quality of life
measure: Stanford Health Assessment Questionnaire
time frame: An average of 1 year
description: measure of functional capacity
arm group label: Control Group
arm group type: Placebo Comparator
description: Control Group will receive self-care guidelines with feet
arm group label: Treatment Group
arm group type: Experimental
description: Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology
intervention type: Other
intervention name: reflexology
arm group label: Treatment Group
other name: massage
intervention type: Other
intervention name: self-care guidelines with feet
arm group label: Control Group
arm group label: Treatment Group
other name: education
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Beatriz Ms Martínez, doctor
role: Principal Investigator
affiliation: Universidade do Vale do Sapucai
facility: 
country: Brazil
citation: Aguiar CC, Vieira AP, Carvalho AF, Montenegro-Junior RM. [Assessment instruments for a Health-Related Quality of Life in diabetes mellitus]. Arq Bras Endocrinol Metabol. 2008 Aug;52(6):931-9. doi: 10.1590/s0004-27302008000600004. Portuguese.
PMID: 18820804
citation: Kaul K, Tarr JM, Ahmad SI, Kohner EM, Chibber R. Introduction to diabetes mellitus. Adv Exp Med Biol. 2012;771:1-11. doi: 10.1007/978-1-4614-5441-0_1.
PMID: 23393665
citation: Tiran D, Chummun H. The physiological basis of reflexology and its use as a potential diagnostic tool. Complement Ther Clin Pract. 2005 Feb;11(1):58-64. doi: 10.1016/j.ctnm.2004.07.007.
PMID: 15984227
citation: Armstrong AR, Thiebaut SP, Brown LJ, Nepal B. Australian adults use complementary and alternative medicine in the treatment of chronic illness: a national study. Aust N Z J Public Health. 2011 Aug;35(4):384-90. doi: 10.1111/j.1753-6405.2011.00745.x.
PMID: 21806735
citation: Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM. The efficacy of reflexology: systematic review. J Adv Nurs. 2008 Jun;62(5):512-20. doi: 10.1111/j.1365-2648.2008.04606.x.
PMID: 18489444
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PMID: 1593914
citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PMID: 5349366
responsible party type: Principal Investigator
investigator affiliation: Universidade do Vale do Sapucai
investigator full name: Beatriz Bertolaccini Martínez
investigator title: Professor
mesh term: Diabetic Foot
sharing ipd: No