<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/NCT04471285</url>
  </required_header>
  <id_info>
    <org_study_id>0115-18-SZMC</org_study_id>
    <nct_id>NCT04471285</nct_id>
  </id_info>
  <brief_title>Symphysiolysis: Acupuncture Therapeutic Benefits: a Randomized Placebo Controlled Study.</brief_title>
  <official_title>Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      a randomized, observer blind and placebo-controlled cross-over study in which true&#xD;
      acupuncture (Verum)(V) was compared to &quot;placebo&quot; acupuncture (P).&#xD;
&#xD;
      the investigators evaluate the effect of the acupuncture on the pain and the ability of the&#xD;
      pregnant patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the investigators recruit women who diagnose with symphysiolisis by having 2 out of 3 of the&#xD;
      follow:&#xD;
&#xD;
        -  Examine for pain or sensitivity to touch on pubic symphysis joint.&#xD;
&#xD;
        -  Modified Trendelenburg's test&#xD;
&#xD;
        -  Active straight leg raise test The trial doctor will mark the woman's chart with a&#xD;
           continuous number that will become her number in the trial, and she will then be&#xD;
           referred to the acupuncturist.&#xD;
&#xD;
      Women will be randomly divided at a 1:1 ratio, according to the randomized number chart&#xD;
      prepared by the trial's statistician. The list of random numbers will be delivered to the&#xD;
      head of the acupuncturist team and it will be the only copy in existence aside from the one&#xD;
      belonging to the statistician. According to that list of numbers, the head acupuncturist will&#xD;
      instruct the acupuncturist on call as to the type of acupuncture to be performed, true (V)&#xD;
      vs. placebo (P) on the participant . The type of acupuncture (V or P) will be recorded in the&#xD;
      woman's chart.&#xD;
&#xD;
      The treatment will be conducted by one of the acupuncturists on staff at the integrative&#xD;
      medical center. All the acupuncturists have many years of experience in treating pregnant&#xD;
      women with Chinese medicine. The acupuncture will be carried out with 0.18/40mm single use&#xD;
      needles. Point selection and numbers of points used will be determined following the&#xD;
      evaluation of the acupuncturist according to the accepted standards of in Chinese medicine.&#xD;
      They will not, however, deviate from the list of true acupuncture points in the list of&#xD;
      possible true paints . Placebo acupuncture will be three to four points selected at random&#xD;
      from the list of placebo points . The acupuncturist's evaluation in the placebo group will be&#xD;
      the same as in the evaluation in the treatment group and the true acupuncture points selected&#xD;
      during that time will be the ones used in case of failure and continued pain following the&#xD;
      first (placebo) treatment, after cross over.&#xD;
&#xD;
      It should be noted that the woman's assessment and the exam will take place before the&#xD;
      acupuncture treatment begins, whether it is the true or placebo group.&#xD;
&#xD;
      Approximately 30 minutes after the acupuncture treatment began, the woman will be asked once&#xD;
      again to assess her level of pain. An improvement of 1.5 marks on the NRS scale is considered&#xD;
      a positive response. Women whose response after 30 minutes of acupuncture is less than this&#xD;
      will be given the opposite acupuncture treatment. Those who received V acupuncture will&#xD;
      receive P acupuncture and those who received P acupuncture will receive V acupuncture. A&#xD;
      woman will be called our team if her pain is significantly worse. She will then receive the&#xD;
      treatment that has been found most effective between the two acupuncture treatments she&#xD;
      received previously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The trial doctor will mark the woman's chart with a continuous number that will become her number in the trial, and she will then be referred to the acupuncturist. , she will receive an acupuncture treatment according to the randomized numbers for acupuncture V or acupuncture P. Approximately 30 minutes after the acupuncture treatment began, the woman will be asked once again to assess her level of pain. An improvement of 1.5 marks on the NRS scale is considered a positive response. Women whose response after 30 minutes of acupuncture is less than this will be given the opposite acupuncture treatment. Those who received V acupuncture will receive P acupuncture and those who received P acupuncture will receive V acupuncture. A woman will be called again if her pain is significantly worse. She will then receive the treatment that has been found most effective between the two acupuncture treatments she received previously.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain improvement</measure>
    <time_frame>30 minutes</time_frame>
    <description>improvement of 1.5 marks on the Numeric Rating Scale (NRS) ( 0-10 , 0=no pain, 10=worst pain) as describe by the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire</measure>
    <time_frame>48-72 hours</time_frame>
    <description>To compare the functional effects of true and Sham acupuncture on the daily activities/ ability of women with symphysiolysis. the Questionnaire check the daily function of 10 daily activity's ( Pain Intensity ,Personal Care (e.g., Washing, Dressing) Lifting,Walking,Sitting,Standing,Sleeping,Social Life,Traveling,Employment / Homemaking).&#xD;
For each section the total possible score is 5: if the first statement - witch represent no restriction -is marked the section score = 0, if the last statement is marked-witch represen severe disability the score is 5.&#xD;
the total score number is calculated by : Score: /50 x 100 = ____% points Example: 16 (total scored-by the patient answers)/ 50 (total possible score) x 100 = 32%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Single Embryo Pregnancy</condition>
  <condition>Gestational Weeks 24-42</condition>
  <condition>Pain/Sensitivity &gt;5 on Numeric Rating Scale (NRS)</condition>
  <arm_group>
    <arm_group_label>true acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patient will get treatment according to the point the will NOT help the symphysiolysis according to the Alternative medicine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>acupuncture</description>
    <arm_group_label>true acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham acupuncture</intervention_name>
    <description>Sham acupuncture</description>
    <arm_group_label>Sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women &gt; 18 years&#xD;
&#xD;
          -  Single embryo pregnancy in week 24-42&#xD;
&#xD;
          -  was diagnosed with symphysiolisis according to written above&#xD;
&#xD;
          -  Pain/sensitivity &gt;5 on NRS scale in symphysis pubis area for more than two weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of proficiency in Hebrew or English&#xD;
&#xD;
          -  Pain from a different source&#xD;
&#xD;
          -  pelvic bone disease or history of severe pelvic bone injury&#xD;
&#xD;
          -  Thrombocytopenia (plt&lt;50.000)&#xD;
&#xD;
          -  Acupuncture treatment is contraindicated&#xD;
&#xD;
          -  High risk pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menachem Oberbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>head of alternative medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sorina Grisaro, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>head of OBGYN department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shari Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shaare Zedek Medical Center</investigator_affiliation>
    <investigator_full_name>jaffea</investigator_full_name>
    <investigator_title>OBGYN resident, MD MPH</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pubic Symphysis Diastasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471285
org study id: 0115-18-SZMC
nct id: NCT04471285
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
a randomized, observer blind and placebo-controlled cross-over study in which true
      acupuncture (Verum)(V) was compared to "placebo" acupuncture (P).

      the investigators evaluate the effect of the acupuncture on the pain and the ability of the
      pregnant patient.
the investigators recruit women who diagnose with symphysiolisis by having 2 out of 3 of the
      follow:

        -  Examine for pain or sensitivity to touch on pubic symphysis joint.

        -  Modified Trendelenburg's test

        -  Active straight leg raise test The trial doctor will mark the woman's chart with a
           continuous number that will become her number in the trial, and she will then be
           referred to the acupuncturist.

      Women will be randomly divided at a 1:1 ratio, according to the randomized number chart
      prepared by the trial's statistician. The list of random numbers will be delivered to the
      head of the acupuncturist team and it will be the only copy in existence aside from the one
      belonging to the statistician. According to that list of numbers, the head acupuncturist will
      instruct the acupuncturist on call as to the type of acupuncture to be performed, true (V)
      vs. placebo (P) on the participant . The type of acupuncture (V or P) will be recorded in the
      woman's chart.

      The treatment will be conducted by one of the acupuncturists on staff at the integrative
      medical center. All the acupuncturists have many years of experience in treating pregnant
      women with Chinese medicine. The acupuncture will be carried out with 0.18/40mm single use
      needles. Point selection and numbers of points used will be determined following the
      evaluation of the acupuncturist according to the accepted standards of in Chinese medicine.
      They will not, however, deviate from the list of true acupuncture points in the list of
      possible true paints . Placebo acupuncture will be three to four points selected at random
      from the list of placebo points . The acupuncturist's evaluation in the placebo group will be
      the same as in the evaluation in the treatment group and the true acupuncture points selected
      during that time will be the ones used in case of failure and continued pain following the
      first (placebo) treatment, after cross over.

      It should be noted that the woman's assessment and the exam will take place before the
      acupuncture treatment begins, whether it is the true or placebo group.

      Approximately 30 minutes after the acupuncture treatment began, the woman will be asked once
      again to assess her level of pain. An improvement of 1.5 marks on the NRS scale is considered
      a positive response. Women whose response after 30 minutes of acupuncture is less than this
      will be given the opposite acupuncture treatment. Those who received V acupuncture will
      receive P acupuncture and those who received P acupuncture will receive V acupuncture. A
      woman will be called our team if her pain is significantly worse. She will then receive the
      treatment that has been found most effective between the two acupuncture treatments she
      received previously.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The trial doctor will mark the woman's chart with a continuous number that will become her number in the trial, and she will then be referred to the acupuncturist. , she will receive an acupuncture treatment according to the randomized numbers for acupuncture V or acupuncture P. Approximately 30 minutes after the acupuncture treatment began, the woman will be asked once again to assess her level of pain. An improvement of 1.5 marks on the NRS scale is considered a positive response. Women whose response after 30 minutes of acupuncture is less than this will be given the opposite acupuncture treatment. Those who received V acupuncture will receive P acupuncture and those who received P acupuncture will receive V acupuncture. A woman will be called again if her pain is significantly worse. She will then receive the treatment that has been found most effective between the two acupuncture treatments she received previously.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: pain improvement
time frame: 30 minutes
description: improvement of 1.5 marks on the Numeric Rating Scale (NRS) ( 0-10 , 0=no pain, 10=worst pain) as describe by the patient.
measure: improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire
time frame: 48-72 hours
description: To compare the functional effects of true and Sham acupuncture on the daily activities/ ability of women with symphysiolysis. the Questionnaire check the daily function of 10 daily activity's ( Pain Intensity ,Personal Care (e.g., Washing, Dressing) Lifting,Walking,Sitting,Standing,Sleeping,Social Life,Traveling,Employment / Homemaking).
For each section the total possible score is 5: if the first statement - witch represent no restriction -is marked the section score = 0, if the last statement is marked-witch represen severe disability the score is 5.
the total score number is calculated by : Score: /50 x 100 = ____% points Example: 16 (total scored-by the patient answers)/ 50 (total possible score) x 100 = 32%
arm group label: true acupuncture
arm group type: Active Comparator
description: patient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine
arm group label: Sham acupuncture
arm group type: Sham Comparator
description: patient will get treatment according to the point the will NOT help the symphysiolysis according to the Alternative medicine
intervention type: Procedure
intervention name: acupuncture
description: acupuncture
arm group label: true acupuncture
intervention type: Procedure
intervention name: Sham acupuncture
description: Sham acupuncture
arm group label: Sham acupuncture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Menachem Oberbaum, MD
role: Principal Investigator
affiliation: head of alternative medicine
last name: Sorina Grisaro, MD PhD
role: Study Director
affiliation: head of OBGYN department
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Shaare Zedek Medical Center
investigator full name: jaffea
investigator title: OBGYN resident, MD MPH
mesh term: Pubic Symphysis Diastasis