<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/NCT02993445</url>
  </required_header>
  <id_info>
    <org_study_id>22105</org_study_id>
    <nct_id>NCT02993445</nct_id>
  </id_info>
  <brief_title>Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension</brief_title>
  <official_title>A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of complementary and alternative&#xD;
      therapies, specifically alternate nostril breathing and foot reflexology, on intraocular&#xD;
      pressure in patients with ocular hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had&#xD;
      ocular hypertension and were between the ages of 48-74. Patients were excluded if they&#xD;
      currently performed ANB or FR, were unable to perform the task, had previous eye surgery or&#xD;
      laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout&#xD;
      period. After a 30-day drug washout, patients completed either ANB or FR. After instruction,&#xD;
      the assigned task was performed for 5 minutes. FR was done on a commercially available foot&#xD;
      reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of&#xD;
      both feet. Two weeks later, patients completed the alternate task. IOP was measured before&#xD;
      the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests&#xD;
      were used to evaluate IOP changes within and between each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Change From Baseline in Intraocular Pressure (mmHg)</measure>
    <time_frame>2 hours</time_frame>
    <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Intraocular Pressure (mmHg)</measure>
    <time_frame>2 hours</time_frame>
    <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.&#xD;
This is after the 2 week washout period. Participants have switched interventions</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Alternate Nostril Breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foot Reflexology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alternate Nostril Breathing</intervention_name>
    <arm_group_label>Alternate Nostril Breathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foot Reflexology</intervention_name>
    <arm_group_label>Foot Reflexology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with ocular hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently performed alternate nostril breathing or foot reflexology&#xD;
&#xD;
          -  were unable to perform the task&#xD;
&#xD;
          -  had previous eye surgery or laser,&#xD;
&#xD;
          -  were receiving other CAM for ocular hypertension&#xD;
&#xD;
          -  were unable to complete a washout period if they using glaucoma eye drops&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Henderer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>October 12, 2020</results_first_submitted>
  <results_first_submitted_qc>November 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2020</results_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After a 30-day drug washout, patients were randomly assigned to complete either ANB or FR for 5 min. After instruction, patients completed either ANB or FR, and completed the alternate task 2 weeks later.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Alternate Nostril Breathing First, Then Foot Reflexology</title>
          <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for foot reflexology.&#xD;
The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.</description>
        </group>
        <group group_id="P2">
          <title>Foot Reflexology First, Then Alternate Nostril Breathing</title>
          <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for alternate nostril breathing.&#xD;
The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (5 Minutes)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (5 Mins)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Alternate Nostril Breathing First, Then Foot Reflexology</title>
          <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.</description>
        </group>
        <group group_id="B2">
          <title>Foot Reflexology First, Then Alternate Nostril Breathing</title>
          <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for alternate nostril breathing.&#xD;
The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.0" spread="9.69"/>
                    <measurement group_id="B2" value="65.4" spread="7.44"/>
                    <measurement group_id="B3" value="62.64" spread="8.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corneal Thickness</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Right Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="567.8" spread="36.78"/>
                    <measurement group_id="B2" value="572.7" spread="37.0"/>
                    <measurement group_id="B3" value="569.6" spread="34.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="568.2" spread="39.7"/>
                    <measurement group_id="B2" value="575.3" spread="53.1"/>
                    <measurement group_id="B3" value="570.88" spread="41.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Intraocular Pressure (mmHg)</title>
        <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology</title>
            <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Foot Reflexology First, Then Alternate Nostril Breathing</title>
            <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for alternate nostril breathing.&#xD;
The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intraocular Pressure (mmHg)</title>
          <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="1.61"/>
                    <measurement group_id="O2" value="26.8" spread="4.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="2.19"/>
                    <measurement group_id="O2" value="22.5" spread="4.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" spread="2.35"/>
                    <measurement group_id="O2" value="22.7" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" spread="2.66"/>
                    <measurement group_id="O2" value="22.5" spread="3.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" spread="2.9"/>
                    <measurement group_id="O2" value="25.3" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Intraocular Pressure (mmHg)</title>
        <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.&#xD;
This is after the 2 week washout period. Participants have switched interventions</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology</title>
            <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Foot Reflexology First, Then Alternate Nostril Breathing</title>
            <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.&#xD;
Patients will complete 2 week wash out and then return for alternate nostril breathing.&#xD;
The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intraocular Pressure (mmHg)</title>
          <description>Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.&#xD;
This is after the 2 week washout period. Participants have switched interventions</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="2.22"/>
                    <measurement group_id="O2" value="26.5" spread="4.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="2.00"/>
                    <measurement group_id="O2" value="23.9" spread="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="2.00"/>
                    <measurement group_id="O2" value="23.45" spread="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" spread="2.08"/>
                    <measurement group_id="O2" value="22.7" spread="4.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="2.23"/>
                    <measurement group_id="O2" value="22.7" spread="3.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 hour after each task patients were assessed for adverse events</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Alternate Nostril Breathing</title>
          <description>The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.&#xD;
Alternate Nostril Breathing</description>
        </group>
        <group group_id="E2">
          <title>Foot Reflexology</title>
          <description>The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.&#xD;
Foot Reflexology</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size; No control group</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Jeffrey Henderer</name_or_title>
      <organization>Temple University Hospital</organization>
      <phone>267-418-9126</phone>
      <email>Jeffrey.Henderer@tuhs.temple.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02993445
org study id: 22105
nct id: NCT02993445
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of complementary and alternative
      therapies, specifically alternate nostril breathing and foot reflexology, on intraocular
      pressure in patients with ocular hypertension.
11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had
      ocular hypertension and were between the ages of 48-74. Patients were excluded if they
      currently performed ANB or FR, were unable to perform the task, had previous eye surgery or
      laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout
      period. After a 30-day drug washout, patients completed either ANB or FR. After instruction,
      the assigned task was performed for 5 minutes. FR was done on a commercially available foot
      reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of
      both feet. Two weeks later, patients completed the alternate task. IOP was measured before
      the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests
      were used to evaluate IOP changes within and between each group.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Intraocular Pressure (mmHg)
time frame: 2 hours
description: Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.
measure: Change From Baseline in Intraocular Pressure (mmHg)
time frame: 2 hours
description: Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.
This is after the 2 week washout period. Participants have switched interventions
arm group label: Alternate Nostril Breathing
arm group type: Experimental
description: The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.
arm group label: Foot Reflexology
arm group type: Experimental
description: The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
intervention type: Other
intervention name: Alternate Nostril Breathing
arm group label: Alternate Nostril Breathing
intervention type: Device
intervention name: Foot Reflexology
arm group label: Foot Reflexology
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Henderer, M.D.
role: Principal Investigator
affiliation: Temple University
responsible party type: Sponsor
mesh term: Ocular Hypertension
mesh term: Glaucoma
mesh term: Hypertension
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size; No control group
point of contact: 