<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/NCT03765853</url>
  </required_header>
  <id_info>
    <org_study_id>2018-50</org_study_id>
    <secondary_id>2018-A01759-46</secondary_id>
    <nct_id>NCT03765853</nct_id>
  </id_info>
  <brief_title>Randomized Study on the Evaluation of the Regular Practice of Standardized Postures Stretching Postural® in Secondary Prevention of Low Back Pains During Pregnancy.</brief_title>
  <acronym>GEMALODO</acronym>
  <official_title>Randomized Study on the Evaluation of the Regular Practice of Standardized Postures Stretching Postural® in Secondary Prevention of Low Back Pains During Pregnancy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Lower back pain (LBP) during pregnancy is a frequent syndrome: it concerns two thirds of&#xD;
      pregnant women. This complaint isn't routinely searched for and therefore underdiagnosed.&#xD;
      Furthermore, few solutions are given to these women in order to reduce their pain, and&#xD;
      indirectly to improve everyday life. What's more, LBP is the cause of many work&#xD;
      interruptions. Physical exercise during pregnancy is recommended by the National College of&#xD;
      Gynaecologists and Obstetricians for low risk pregnancies. Several techniques have proven to&#xD;
      be efficient.&#xD;
&#xD;
      The main objective of our study is to assess the benefit of regular practice of standardised&#xD;
      Stretching Postural® postures in patients presenting &quot;de novo&quot; lower back pain during&#xD;
      pregnancy.&#xD;
&#xD;
      The Stretching Postural® technique comprises of static postures involving muscular&#xD;
      contractions and stretches. This allows the strengthening of the postural muscles, including&#xD;
      the paravertebral muscles. After a short learning period, postures can be done autonomously&#xD;
      by the patients. The postures are adaptable to each and everyone's morphology and physical&#xD;
      limitations.&#xD;
&#xD;
      Our study is an open, prospective, randomised monocentric superiority trial in parallel&#xD;
      branches involving major patients during low risk pregnancies. These women suffer from &quot;de&#xD;
      novo&quot; lower back pain during the second and third trimesters of their pregnancies. Each&#xD;
      patient will be randomly assigned to one of the following 2 groups:&#xD;
&#xD;
        -  Stretching Postural® group (group A): usual prevention methods (ergonomic education) and&#xD;
           Stretching Postural® postures.&#xD;
&#xD;
        -  &quot;Control&quot; group (group B): usual prevention methods only.&#xD;
&#xD;
      Patients presenting &quot;de novo&quot; LBP are included in the study after a routine consult then&#xD;
      randomly separated into two groups. During the initial consult, the physician assesses&#xD;
      inclusion and judgement criteria, collects informed consent from the patients and teaches&#xD;
      them the usual prevention methods as well as, concerning group A, Stretching Postural®&#xD;
      postures. Computerized support agendas are given in order to improve observance.&#xD;
&#xD;
      Patients are evaluated at day 0 (initial evaluation), after 4 weeks (intermediate) and after&#xD;
      8 weeks (final), according to the main judgment criterion, as well as on secondary pain&#xD;
      criteria by the Concise Pain Questionnaire, on their quality of life, the rate of work&#xD;
      interruptions and their satisfaction rate. Neonatal outcome is collected at birth.&#xD;
      Intermediate phone interviews will allow psychological support and improve observance.&#xD;
      Inclusion is scheduled to last 22 months; each subject will be followed during a period of 2&#xD;
      months. The total duration of the study is 2 years.&#xD;
&#xD;
      Expected results are a decrease in back pain and an improvement of the quality of life in&#xD;
      group A. Decrease in pain scale, equivalent to overall pain during the last week between the&#xD;
      two groups will be our main judgment criterion. In order to detect a difference of 1.5 pain&#xD;
      scale points (on a scale from 1 to 10) with an alpha risk of 5%, 80% magnitude and a standard&#xD;
      deviation of 2, 56 subjects are necessary; 28 in each group.&#xD;
&#xD;
      Perspectives: This study will allow for a better diagnosis of lower back pain during&#xD;
      pregnancy, and, consequently, for the implementation of routine means of care such as&#xD;
      collective or private lessons in Stretching Postural® and the supply of personalised&#xD;
      prevention documents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Lower Back Pain</measure>
    <time_frame>2 months</time_frame>
    <description>Evaluated on the Numeric Pain Rating Scale (0 = No pain to 10 = Worst possible pain). This scale, validated, is a self-assessment of the average pain felt during the last week collecting by an evaluation questionnaire. It's part of Concise Pain Questionnaire's questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the analgesic efficacity on the Numeric Pain Rating Scale representing the average pain on the last week at 4 weeks.</measure>
    <time_frame>week 4</time_frame>
    <description>Evaluated on the Numeric Pain Rating Scale (0 = No pain to 10 = Worst possible pain). Questionnaire will be completed during intermediate consultation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Stretching Postural®</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Usual prevention methods (ergonomic education) and Stretching Postural® postures.</description>
    <arm_group_label>Stretching Postural®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients between 15 and 32 amenorrhea at the beginning of the study&#xD;
&#xD;
          -  Absence of pre existing major lower back pain&#xD;
&#xD;
          -  Back or lumbar pain and/or sacroiliac&#xD;
&#xD;
          -  Good understanding of French&#xD;
&#xD;
          -  BMI before pregnancy &lt;35&#xD;
&#xD;
          -  singletons&#xD;
&#xD;
          -  Low risk pregnancy : no maternal and foetal major pathology (absence of professional&#xD;
             risk, no antecedent of obstetric pathology, major gynecological pathology, exposure to&#xD;
             toxic, important medical risk factors, infectious disease)&#xD;
&#xD;
          -  Possibility to listen a computer audio&#xD;
&#xD;
          -  Patient having accepted to participate to the study and having signed informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical handicap not allowing the change of positions in autonomy&#xD;
&#xD;
          -  Severe cardiac, lung,hepatic, rheumatological pathology&#xD;
&#xD;
          -  Sciatic without LPB (Low Back Pain), motor deficit or slipped disc&#xD;
&#xD;
          -  High risk pregnancy&#xD;
&#xD;
          -  maternal plan : antecedent of late miscarriage, cervix cerclage, disease having an&#xD;
             impact on pregnancy, unbalanced diabetes insulin.&#xD;
&#xD;
          -  foetal plan : multiple pregnancy, severe intrauterine growth retardation, severe&#xD;
             foetal pathology.&#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>Jean Olivier Arnaud, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique - Hôpital Nord</name>
      <address>
        <city>Marseille</city>
        <state>Marseille Cedex</state>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</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>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03765853
org study id: 2018-50
secondary id: 2018-A01759-46
nct id: NCT03765853
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lower back pain (LBP) during pregnancy is a frequent syndrome: it concerns two thirds of
      pregnant women. This complaint isn't routinely searched for and therefore underdiagnosed.
      Furthermore, few solutions are given to these women in order to reduce their pain, and
      indirectly to improve everyday life. What's more, LBP is the cause of many work
      interruptions. Physical exercise during pregnancy is recommended by the National College of
      Gynaecologists and Obstetricians for low risk pregnancies. Several techniques have proven to
      be efficient.

      The main objective of our study is to assess the benefit of regular practice of standardised
      Stretching Postural® postures in patients presenting "de novo" lower back pain during
      pregnancy.

      The Stretching Postural® technique comprises of static postures involving muscular
      contractions and stretches. This allows the strengthening of the postural muscles, including
      the paravertebral muscles. After a short learning period, postures can be done autonomously
      by the patients. The postures are adaptable to each and everyone's morphology and physical
      limitations.

      Our study is an open, prospective, randomised monocentric superiority trial in parallel
      branches involving major patients during low risk pregnancies. These women suffer from "de
      novo" lower back pain during the second and third trimesters of their pregnancies. Each
      patient will be randomly assigned to one of the following 2 groups:

        -  Stretching Postural® group (group A): usual prevention methods (ergonomic education) and
           Stretching Postural® postures.

        -  "Control" group (group B): usual prevention methods only.

      Patients presenting "de novo" LBP are included in the study after a routine consult then
      randomly separated into two groups. During the initial consult, the physician assesses
      inclusion and judgement criteria, collects informed consent from the patients and teaches
      them the usual prevention methods as well as, concerning group A, Stretching Postural®
      postures. Computerized support agendas are given in order to improve observance.

      Patients are evaluated at day 0 (initial evaluation), after 4 weeks (intermediate) and after
      8 weeks (final), according to the main judgment criterion, as well as on secondary pain
      criteria by the Concise Pain Questionnaire, on their quality of life, the rate of work
      interruptions and their satisfaction rate. Neonatal outcome is collected at birth.
      Intermediate phone interviews will allow psychological support and improve observance.
      Inclusion is scheduled to last 22 months; each subject will be followed during a period of 2
      months. The total duration of the study is 2 years.

      Expected results are a decrease in back pain and an improvement of the quality of life in
      group A. Decrease in pain scale, equivalent to overall pain during the last week between the
      two groups will be our main judgment criterion. In order to detect a difference of 1.5 pain
      scale points (on a scale from 1 to 10) with an alpha risk of 5%, 80% magnitude and a standard
      deviation of 2, 56 subjects are necessary; 28 in each group.

      Perspectives: This study will allow for a better diagnosis of lower back pain during
      pregnancy, and, consequently, for the implementation of routine means of care such as
      collective or private lessons in Stretching Postural® and the supply of personalised
      prevention documents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Lower Back Pain
time frame: 2 months
description: Evaluated on the Numeric Pain Rating Scale (0 = No pain to 10 = Worst possible pain). This scale, validated, is a self-assessment of the average pain felt during the last week collecting by an evaluation questionnaire. It's part of Concise Pain Questionnaire's questions.
measure: Assessment of the analgesic efficacity on the Numeric Pain Rating Scale representing the average pain on the last week at 4 weeks.
time frame: week 4
description: Evaluated on the Numeric Pain Rating Scale (0 = No pain to 10 = Worst possible pain). Questionnaire will be completed during intermediate consultation.
arm group label: Stretching Postural®
arm group type: Other
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Physiotherapy
description: Usual prevention methods (ergonomic education) and Stretching Postural® postures.
arm group label: Stretching Postural®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Olivier Arnaud, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain