<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/NCT04404829</url>
  </required_header>
  <id_info>
    <org_study_id>Poyet-Pialoux method</org_study_id>
    <nct_id>NCT04404829</nct_id>
  </id_info>
  <brief_title>Informational Manual Therapy to Improve Standing Balance</brief_title>
  <official_title>The Effect of the Informational Manual Therapy for Improving Quiet Standing, Pain and Quality of Life in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Internacional de Catalunya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitat Internacional de Catalunya</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>
      Objectives: The aim of this study is to assess the effect of Informational Manual Therapy&#xD;
      (IMT) on quiet standing and quality of life in healthy individuals. The IMT also is known as&#xD;
      the Poyet-Pialoux method, is a holistic, no orthopedic, and soft manual therapy.&#xD;
&#xD;
      Design: This is a one-group pretest-posttest design. It is a within-subjects experiment in&#xD;
      which each participant is tested first under the control condition and then under the&#xD;
      treatment condition.&#xD;
&#xD;
      Setting: University laboratory. Intervention: One IMT session was performed on 57 healthy&#xD;
      individuals aged from 18 to 65 years. They were grouped into three age groups. The treatment&#xD;
      session was performed by 5 therapists on two days. The primary outcome was quite standing&#xD;
      assessed by the SATEL force platform. Secondary outcomes were bodily pain assessed by the&#xD;
      pain sections of the 36-Item Short Form Survey (SF-36) and quality of life by EQ-5D-3L&#xD;
      (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The primary&#xD;
      outcome was evaluated before and immediately after treatment and after 7-10 days. The&#xD;
      secondary outcomes were assessed after treatment and 3 weeks later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods Study Design: The study has a one-group pretest-posttest design. The personal data of&#xD;
      individuals were kept confidential and the data were shared anonymously upon request from the&#xD;
      principal researcher. The TREND statement will be followed.&#xD;
&#xD;
      Subjects Fifty-seven participants will be recruited to participate in this study; the sample&#xD;
      was one of convenience. The inclusion and exclusion criteria are as follows: age from 18 to&#xD;
      65 years old, not having a positive diagnosis for any disease which influences balance, no&#xD;
      participation in any other trial, not suffering from an injury in the 3 months before the&#xD;
      study or fractures in the previous 6 months, and no falls in the previous month. All&#xD;
      individuals provided informed consent before enrolment.&#xD;
&#xD;
      Intervention All the participants received a single session of 30-45 min of IMT. All the&#xD;
      treatment sessions took place at the UIC laboratory. The IMT session was performed over two&#xD;
      days by four physiotherapists and a doctor. All have more than five years of experience in&#xD;
      IMT treatment.&#xD;
&#xD;
      The first level of IMT was treated in this study: the objective is to harmonize the&#xD;
      Cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture.&#xD;
      The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis.&#xD;
      The first is considered a key area for the correct transmission of forces and loads from the&#xD;
      lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this&#xD;
      purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. At this&#xD;
      level. Compensatory injuries that the body has started after a primary injury are treated on&#xD;
      this level, through the Fluidic Chains. This also includes the treatment of some traumatic&#xD;
      injuries, such as cranial strains, the compression of spheno-basilar synchondrosis, injuries&#xD;
      of the pelvis and occipital bone, and damage to the flexion-extension and lateral&#xD;
      displacement of the vertebrae. The diagnosis of this level is performed by cranial somotopias&#xD;
      (reflex points on the skull and face). Practically all the treatment is carried out on the&#xD;
      sacrum. The first step is the &quot;fuses,&quot; which are vibration zones that act as a protection&#xD;
      system for the body (1). These points sometimes stop working, which interrupts the correct&#xD;
      movement of the PRM: 1st fuse: Inn-trang (on the forehead between the two eyebrows, the 4th&#xD;
      sacral vertebra is stimulated if it is not adjusted). A massage on the scalp in several very&#xD;
      soft circles that goes from the frontal to the occipital area is performed 6 times. 2nd fuse:&#xD;
      1st dorsal vertebra, 4th cervical, 4th dorsal, and 3rd lumbar. 3rd fuse: C0 (base of the&#xD;
      occipital), a zone of the 2nd sacral vertebra, and the space between the spines of the 2nd&#xD;
      and 3rd dorsal vertebrae and finally point R1 (between the 2nd and 3 rd metatarsal). If any&#xD;
      point is blocked it is treated and harmonized with a soft touch towards the occipital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study has a one-group pretest-posttest design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>static standing posture</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>static standing posture</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How much bodily pain have you had during the past 4 weeks?</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How much bodily pain have you had during the past 4 weeks?</measure>
    <time_frame>three weeks, post-intervention</time_frame>
    <description>by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?</measure>
    <time_frame>three weeks after treatment</time_frame>
    <description>by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mobility</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mobility</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-care</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-care</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>usual activities</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>usual activities</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain/discomfort</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain/discomfort</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety/depression</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety/depression</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analogue scale for health</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>by the EQ-VAS, ranging from 0 (&quot;worst possible&quot;) to 100 (&quot;best possible&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analogue scale for health</measure>
    <time_frame>three weeks post-intervention</time_frame>
    <description>by the EQ-VAS, ranging from 0 (&quot;worst possible&quot;) to 100 (&quot;best possible&quot;).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Balance Postural</condition>
  <condition>Pain</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Informational Manual Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is an integral no orthopedic and very soft manual therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>The first level of IMT was treated in this study: the objective is to harmonize the cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture. The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis. The first is considered a key area for the correct transmission of forces and loads from the lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. In this level. Compensatory injuries that the body has started after a primary injury are treated on this level, through the Fluidic Chains. The diagnosis of this level is performed by cranial somotopias. Practically all the treatment is carried out on the sacrum. The first step are the &quot;fuses,&quot; which are vibration zones which act as a protection system for the body. These points sometimes stop working, which interrupts the correct movement of the PRM.</description>
    <arm_group_label>Informational Manual Therapy</arm_group_label>
    <other_name>Poyet-Pialoux method</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy people&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not having problems with balance, Not suffering from an injury in the 3 months before the&#xD;
        study, Not suffering from a fracture in the previous 6 month before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Cabanas Valdés, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat Internacional de Catalunya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitat Internacional de Catalunya</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://halldulivre.com/livre/9782364031005-osteopathie-non-structurelle-a-l-ecoute-du-corps-une-evolution-de-la-methode-poyet-jean-marchandise-anne-paul-marchandise/</url>
    <description>Ostéopathie non structurelle ; à l'écoute du corps, une évolution de la méthode Poyet</description>
  </link>
  <results_reference>
    <citation>Bordoni B, Zanier E. Sutherland's legacy in the new millennium: the osteopathic cranial model and modern osteopathy. Adv Mind Body Med. 2015 Spring;29(2):15-21.</citation>
    <PMID>25831430</PMID>
  </results_reference>
  <results_reference>
    <citation>Tseui JJ. Eastern and western approaches to medicine. West J Med. 1978 Jun;128(6):551-7.</citation>
    <PMID>664653</PMID>
  </results_reference>
  <results_reference>
    <citation>Liem T, Neuhuber W. Osteopathic Treatment Approach to Psychoemotional Trauma by Means of Bifocal Integration. J Am Osteopath Assoc. 2020 Mar 1;120(3):180-189. doi: 10.7556/jaoa.2020.021.</citation>
    <PMID>32091561</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee RP. The living matrix: a model for the primary respiratory mechanism. Explore (NY). 2008 Nov-Dec;4(6):374-8. doi: 10.1016/j.explore.2008.08.003.</citation>
    <PMID>18984549</PMID>
  </results_reference>
  <results_reference>
    <citation>Frymann VM. A study of the rhythmic motions of the living cranium. J Am Osteopath Assoc. 1971 May;70(9):928-45. No abstract available.</citation>
    <PMID>5207590</PMID>
  </results_reference>
  <results_reference>
    <citation>Ballester-Rodes M, Carreras-Costa F, Versyp-Ducaju T, Ballester-Rodes M, Mehta D. Field dynamics in atrioventricular activation. Clinical evidence of a specific field-to-protein interaction. Med Hypotheses. 2019 Mar;124:56-59. doi: 10.1016/j.mehy.2019.02.012. Epub 2019 Feb 2.</citation>
    <PMID>30798917</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation>
    <investigator_full_name>Rosa Cabanas Valdés</investigator_full_name>
    <investigator_title>Universitat Internacional de Catalunya</investigator_title>
  </responsible_party>
  <keyword>balance</keyword>
  <keyword>pain</keyword>
  <keyword>quality of life</keyword>
  <keyword>manual therapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not any plan</ipd_description>
  </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/NCT04404829
org study id: Poyet-Pialoux method
nct id: NCT04404829
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: The aim of this study is to assess the effect of Informational Manual Therapy
      (IMT) on quiet standing and quality of life in healthy individuals. The IMT also is known as
      the Poyet-Pialoux method, is a holistic, no orthopedic, and soft manual therapy.

      Design: This is a one-group pretest-posttest design. It is a within-subjects experiment in
      which each participant is tested first under the control condition and then under the
      treatment condition.

      Setting: University laboratory. Intervention: One IMT session was performed on 57 healthy
      individuals aged from 18 to 65 years. They were grouped into three age groups. The treatment
      session was performed by 5 therapists on two days. The primary outcome was quite standing
      assessed by the SATEL force platform. Secondary outcomes were bodily pain assessed by the
      pain sections of the 36-Item Short Form Survey (SF-36) and quality of life by EQ-5D-3L
      (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The primary
      outcome was evaluated before and immediately after treatment and after 7-10 days. The
      secondary outcomes were assessed after treatment and 3 weeks later.
Methods Study Design: The study has a one-group pretest-posttest design. The personal data of
      individuals were kept confidential and the data were shared anonymously upon request from the
      principal researcher. The TREND statement will be followed.

      Subjects Fifty-seven participants will be recruited to participate in this study; the sample
      was one of convenience. The inclusion and exclusion criteria are as follows: age from 18 to
      65 years old, not having a positive diagnosis for any disease which influences balance, no
      participation in any other trial, not suffering from an injury in the 3 months before the
      study or fractures in the previous 6 months, and no falls in the previous month. All
      individuals provided informed consent before enrolment.

      Intervention All the participants received a single session of 30-45 min of IMT. All the
      treatment sessions took place at the UIC laboratory. The IMT session was performed over two
      days by four physiotherapists and a doctor. All have more than five years of experience in
      IMT treatment.

      The first level of IMT was treated in this study: the objective is to harmonize the
      Cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture.
      The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis.
      The first is considered a key area for the correct transmission of forces and loads from the
      lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this
      purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. At this
      level. Compensatory injuries that the body has started after a primary injury are treated on
      this level, through the Fluidic Chains. This also includes the treatment of some traumatic
      injuries, such as cranial strains, the compression of spheno-basilar synchondrosis, injuries
      of the pelvis and occipital bone, and damage to the flexion-extension and lateral
      displacement of the vertebrae. The diagnosis of this level is performed by cranial somotopias
      (reflex points on the skull and face). Practically all the treatment is carried out on the
      sacrum. The first step is the "fuses," which are vibration zones that act as a protection
      system for the body (1). These points sometimes stop working, which interrupts the correct
      movement of the PRM: 1st fuse: Inn-trang (on the forehead between the two eyebrows, the 4th
      sacral vertebra is stimulated if it is not adjusted). A massage on the scalp in several very
      soft circles that goes from the frontal to the occipital area is performed 6 times. 2nd fuse:
      1st dorsal vertebra, 4th cervical, 4th dorsal, and 3rd lumbar. 3rd fuse: C0 (base of the
      occipital), a zone of the 2nd sacral vertebra, and the space between the spines of the 2nd
      and 3rd dorsal vertebrae and finally point R1 (between the 2nd and 3 rd metatarsal). If any
      point is blocked it is treated and harmonized with a soft touch towards the occipital.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study has a one-group pretest-posttest design.
primary purpose: Treatment
masking: None (Open Label)
measure: static standing posture
time frame: baseline, pre-intervention
description: It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France).
measure: static standing posture
time frame: immediately after the intervention
description: It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France).
measure: How much bodily pain have you had during the past 4 weeks?
time frame: baseline, pre-intervention
description: by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe
measure: How much bodily pain have you had during the past 4 weeks?
time frame: three weeks, post-intervention
description: by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe
measure: During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
time frame: baseline, pre-intervention
description: by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely
measure: During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
time frame: three weeks after treatment
description: by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely
measure: mobility
time frame: baseline, pre-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: mobility
time frame: three weeks post-intervention
description: by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: self-care
time frame: baseline, pre-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: self-care
time frame: three weeks post-intervention
description: by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: usual activities
time frame: baseline, pre-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: usual activities
time frame: three weeks post-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: pain/discomfort
time frame: baseline, pre-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: pain/discomfort
time frame: three weeks post-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: anxiety/depression
time frame: baseline, pre-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: anxiety/depression
time frame: three weeks post-intervention
description: by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems
measure: visual analogue scale for health
time frame: baseline, pre-intervention
description: by the EQ-VAS, ranging from 0 ("worst possible") to 100 ("best possible").
measure: visual analogue scale for health
time frame: three weeks post-intervention
description: by the EQ-VAS, ranging from 0 ("worst possible") to 100 ("best possible").
arm group label: Informational Manual Therapy
arm group type: Experimental
description: It is an integral no orthopedic and very soft manual therapy
intervention type: Other
intervention name: Manual Therapy
description: The first level of IMT was treated in this study: the objective is to harmonize the cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture. The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis. The first is considered a key area for the correct transmission of forces and loads from the lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. In this level. Compensatory injuries that the body has started after a primary injury are treated on this level, through the Fluidic Chains. The diagnosis of this level is performed by cranial somotopias. Practically all the treatment is carried out on the sacrum. The first step are the "fuses," which are vibration zones which act as a protection system for the body. These points sometimes stop working, which interrupts the correct movement of the PRM.
arm group label: Informational Manual Therapy
other name: Poyet-Pialoux method
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Cabanas Valdés, PhD
role: Principal Investigator
affiliation: Universitat Internacional de Catalunya
facility: 
country: Spain
url: https://halldulivre.com/livre/9782364031005-osteopathie-non-structurelle-a-l-ecoute-du-corps-une-evolution-de-la-methode-poyet-jean-marchandise-anne-paul-marchandise/
description: Ostéopathie non structurelle ; à l'écoute du corps, une évolution de la méthode Poyet
citation: Bordoni B, Zanier E. Sutherland's legacy in the new millennium: the osteopathic cranial model and modern osteopathy. Adv Mind Body Med. 2015 Spring;29(2):15-21.
PMID: 25831430
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PMID: 664653
citation: Liem T, Neuhuber W. Osteopathic Treatment Approach to Psychoemotional Trauma by Means of Bifocal Integration. J Am Osteopath Assoc. 2020 Mar 1;120(3):180-189. doi: 10.7556/jaoa.2020.021.
PMID: 32091561
citation: Lee RP. The living matrix: a model for the primary respiratory mechanism. Explore (NY). 2008 Nov-Dec;4(6):374-8. doi: 10.1016/j.explore.2008.08.003.
PMID: 18984549
citation: Frymann VM. A study of the rhythmic motions of the living cranium. J Am Osteopath Assoc. 1971 May;70(9):928-45. No abstract available.
PMID: 5207590
citation: Ballester-Rodes M, Carreras-Costa F, Versyp-Ducaju T, Ballester-Rodes M, Mehta D. Field dynamics in atrioventricular activation. Clinical evidence of a specific field-to-protein interaction. Med Hypotheses. 2019 Mar;124:56-59. doi: 10.1016/j.mehy.2019.02.012. Epub 2019 Feb 2.
PMID: 30798917
responsible party type: Principal Investigator
investigator affiliation: Universitat Internacional de Catalunya
investigator full name: Rosa Cabanas Valdés
investigator title: Universitat Internacional de Catalunya
sharing ipd: No
ipd description: There is not any plan