<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/NCT04415996</url>
  </required_header>
  <id_info>
    <org_study_id>OST1-004</org_study_id>
    <nct_id>NCT04415996</nct_id>
  </id_info>
  <brief_title>L3/L4 High Velocity Low Amplitude Technique Influence On Baropodometric Pressures In Healthy Young Adults</brief_title>
  <official_title>L3/L4 High Velocity Low Amplitude Technique Influence On Baropodometric Pressures In Healthy Young Adults: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Escola Superior de Tecnologia da Saúde do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Escola Superior de Tecnologia da Saúde do Porto</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>
      In this double-blinded study, the objective is to determine the effects of bilateral High&#xD;
      Velocity Low Amplitude (HVLA) technique on L3/L4 joint in baropodometric pressures in 60&#xD;
      healthy young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The postural control it´s a fundamental aspect to understand the human´s capacity to perform&#xD;
      activities. These balance is controlled by several mechanisms such as the proprioceptive&#xD;
      system of muscles and articulation joints.&#xD;
&#xD;
      It is known that the High Velocity Low Amplitude (HVLA) technique shows biomechanical and&#xD;
      neurophysiologic effects.&#xD;
&#xD;
      By saying that, it is importance to understand the effects of the lumbar manipulation on&#xD;
      body´s weight distribution. Therefore, there is going to be measure several variables such as&#xD;
      center of pressure oscillation , plantar pressure distribution and plantar contact area using&#xD;
      a pressure platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Each participant will pull from a bag within equally number of folded papers with letter A (Intervention Group) and letter B (Control Group) and it will be handled to the investigator.&#xD;
The outcome assessors won´t also have any contact with the investigator and participant whilst intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline of center of pressure displacement after intervention</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>To obtain the center of pressure displacement measurements, it will be used Emed / CL program. This outcome will be measured either in sagittal plane in anteroposterior direction (x-axis) and in frontal plane in medial-lateral direction (y-axis) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. The Emed/ CL program will determine the This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline of plantar pressure mean</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Plantar pressure mean is measure by Emed / CL program. It´s the average of all pressure values for each measurement, divided by the number of measurements for each sensor. The pressure unit used is Kilopascals (kPa).&#xD;
The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline of plantar contact area</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Plantar contact area corresponds to the measurement of the contact region of the foot with the platform sensors. It is determined by the sum of the area of all sensors activated within a given region.The plantar contact area unit is cm2 (square centimeters) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>HVLA L3/4 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform.&#xD;
Next, the investigator will perform the HVLA technique in L3/L4 joint articulation.&#xD;
Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform.&#xD;
Next, the investigator will perform a Sham technique. Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HVLA L3/4</intervention_name>
    <description>The participant will be lateral decubitus and the investigator will locate the third lumbar vertebra. Then with one hand the investigator will contact the interspinous space underlying L3 and with the other hand he will take the top leg into flexion until the investigator feels tension in L3/L4 joint. Then he puls the tables´s arm until felling tension in the region to be manipulated. Afterwards the investigator will globally rotate the participant in the horizontal plane and will approach to the L3/L4 joint. With one arm the investigator will contact the deltopectoral groove and with the other one will contact the external iliac fossa. Finally, the investigator will compress and rotate the pelvis and will apply an impulse in a rapid rotation, without losing the parameters with a &quot;body drop&quot; allowed by the flexion of the knees and the contraction of the large pectorals.</description>
    <arm_group_label>HVLA L3/4 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>The participant will be in lateral decubitus and the top leg and knee will be flexed until the foot reaches the popliteal region of the other leg. There won't be applied any tension in no structure. This intervention will be applied during 90 seconds each side.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged between 18-25 years old;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  With the follow conditions: lumbar discal hernia, spondylolisthesis with neurologic&#xD;
             influence, narrowing of medullar canal, rheumatic disease, orthopaedic or neurologic&#xD;
             conditions such as diminished sensibility, lack or absence of muscular strength,&#xD;
             absence of patellar and/or aquilus reflexes;&#xD;
&#xD;
          -  History of chirurgical intervention either on lumbar or lower limbs in the past 6&#xD;
             months;&#xD;
&#xD;
          -  History of any trauma on the lumbar spine or lower limbs in the past 6 months;&#xD;
&#xD;
          -  Any type of treatment on the lumbar in the previous month: that implicates&#xD;
             physiotherapy, osteopathy, chiropractic, myofascial treatment, acupuncture or others;&#xD;
&#xD;
          -  Medication that affects the vestibular system (dizziness, vertigo and humming)&#xD;
&#xD;
          -  Pain during que experimental study;&#xD;
&#xD;
          -  Difference between the length of the lower limbs: above 1.5cm;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natália MO Campelo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Escola Superior de Tecnologia da Saúde do Porto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natália MO Campelo, PhD</last_name>
    <phone>00351 22 206 1000</phone>
    <email>ncampelo.estsp.ipp@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Escola Superior da Saúde do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Mendez-Sanchez R, Gonzalez-Iglesias J, Sanchez-Sanchez JL, Puente-Gonzalez AS. Immediate effects of bilateral sacroiliac joint manipulation on plantar pressure distribution in asymptomatic participants. J Altern Complement Med. 2014 Apr;20(4):251-7. doi: 10.1089/acm.2013.0192. Epub 2014 Feb 4.</citation>
    <PMID>24494737</PMID>
  </reference>
  <reference>
    <citation>Gyer G, Michael J, Inklebarger J, Tedla JS. Spinal manipulation therapy: Is it all about the brain? A current review of the neurophysiological effects of manipulation. J Integr Med. 2019 Sep;17(5):328-337. doi: 10.1016/j.joim.2019.05.004. Epub 2019 May 9.</citation>
    <PMID>31105036</PMID>
  </reference>
  <reference>
    <citation>Grassi Dde O, de Souza MZ, Ferrareto SB, Montebelo MI, Guirro EC. Immediate and lasting improvements in weight distribution seen in baropodometry following a high-velocity, low-amplitude thrust manipulation of the sacroiliac joint. Man Ther. 2011 Oct;16(5):495-500. doi: 10.1016/j.math.2011.04.003. Epub 2011 May 14.</citation>
    <PMID>21570892</PMID>
  </reference>
  <reference>
    <citation>Garcia AN, Gondo FL, Costa RA, Cyrillo FN, Silva TM, Costa LC, Costa LO. Effectiveness of the back school and mckenzie techniques in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Aug 5;12:179. doi: 10.1186/1471-2474-12-179.</citation>
    <PMID>21819594</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Escola Superior de Tecnologia da Saúde do Porto</investigator_affiliation>
    <investigator_full_name>Natália Maria Oliveira Campelo</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Lumbar Manipulation</keyword>
  <keyword>High Velocity Low Amplitude (HVLA) technique</keyword>
  <keyword>Baropodometry</keyword>
  <keyword>Osteopathy</keyword>
  <keyword>Plantar Weight Distribution</keyword>
  <!-- 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/NCT04415996
org study id: OST1-004
nct id: NCT04415996
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this double-blinded study, the objective is to determine the effects of bilateral High
      Velocity Low Amplitude (HVLA) technique on L3/L4 joint in baropodometric pressures in 60
      healthy young adults.
The postural control it´s a fundamental aspect to understand the human´s capacity to perform
      activities. These balance is controlled by several mechanisms such as the proprioceptive
      system of muscles and articulation joints.

      It is known that the High Velocity Low Amplitude (HVLA) technique shows biomechanical and
      neurophysiologic effects.

      By saying that, it is importance to understand the effects of the lumbar manipulation on
      body´s weight distribution. Therefore, there is going to be measure several variables such as
      center of pressure oscillation , plantar pressure distribution and plantar contact area using
      a pressure platform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Each participant will pull from a bag within equally number of folded papers with letter A (Intervention Group) and letter B (Control Group) and it will be handled to the investigator.
The outcome assessors won´t also have any contact with the investigator and participant whilst intervention.
measure: Change from Baseline of center of pressure displacement after intervention
time frame: Immediately after the intervention
description: To obtain the center of pressure displacement measurements, it will be used Emed / CL program. This outcome will be measured either in sagittal plane in anteroposterior direction (x-axis) and in frontal plane in medial-lateral direction (y-axis) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. The Emed/ CL program will determine the This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.
measure: Change from Baseline of plantar pressure mean
time frame: Immediately after the intervention
description: Plantar pressure mean is measure by Emed / CL program. It´s the average of all pressure values for each measurement, divided by the number of measurements for each sensor. The pressure unit used is Kilopascals (kPa).
The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.
measure: Change from Baseline of plantar contact area
time frame: Immediately after the intervention
description: Plantar contact area corresponds to the measurement of the contact region of the foot with the platform sensors. It is determined by the sum of the area of all sensors activated within a given region.The plantar contact area unit is cm2 (square centimeters) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation.
arm group label: HVLA L3/4 Group
arm group type: Experimental
description: In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform.
Next, the investigator will perform the HVLA technique in L3/L4 joint articulation.
Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention.
arm group label: Control Group
arm group type: Sham Comparator
description: In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform.
Next, the investigator will perform a Sham technique. Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention.
intervention type: Other
intervention name: HVLA L3/4
description: The participant will be lateral decubitus and the investigator will locate the third lumbar vertebra. Then with one hand the investigator will contact the interspinous space underlying L3 and with the other hand he will take the top leg into flexion until the investigator feels tension in L3/L4 joint. Then he puls the tables´s arm until felling tension in the region to be manipulated. Afterwards the investigator will globally rotate the participant in the horizontal plane and will approach to the L3/L4 joint. With one arm the investigator will contact the deltopectoral groove and with the other one will contact the external iliac fossa. Finally, the investigator will compress and rotate the pelvis and will apply an impulse in a rapid rotation, without losing the parameters with a "body drop" allowed by the flexion of the knees and the contraction of the large pectorals.
arm group label: HVLA L3/4 Group
intervention type: Other
intervention name: Sham
description: The participant will be in lateral decubitus and the top leg and knee will be flexed until the foot reaches the popliteal region of the other leg. There won't be applied any tension in no structure. This intervention will be applied during 90 seconds each side.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Natália MO Campelo, PhD
role: Principal Investigator
affiliation: Escola Superior de Tecnologia da Saúde do Porto
last name: Natália MO Campelo, PhD
phone: 00351 22 206 1000
email: ncampelo.estsp.ipp@gmail.com
facility: 
country: Portugal
citation: Mendez-Sanchez R, Gonzalez-Iglesias J, Sanchez-Sanchez JL, Puente-Gonzalez AS. Immediate effects of bilateral sacroiliac joint manipulation on plantar pressure distribution in asymptomatic participants. J Altern Complement Med. 2014 Apr;20(4):251-7. doi: 10.1089/acm.2013.0192. Epub 2014 Feb 4.
PMID: 24494737
citation: Gyer G, Michael J, Inklebarger J, Tedla JS. Spinal manipulation therapy: Is it all about the brain? A current review of the neurophysiological effects of manipulation. J Integr Med. 2019 Sep;17(5):328-337. doi: 10.1016/j.joim.2019.05.004. Epub 2019 May 9.
PMID: 31105036
citation: Grassi Dde O, de Souza MZ, Ferrareto SB, Montebelo MI, Guirro EC. Immediate and lasting improvements in weight distribution seen in baropodometry following a high-velocity, low-amplitude thrust manipulation of the sacroiliac joint. Man Ther. 2011 Oct;16(5):495-500. doi: 10.1016/j.math.2011.04.003. Epub 2011 May 14.
PMID: 21570892
citation: Garcia AN, Gondo FL, Costa RA, Cyrillo FN, Silva TM, Costa LC, Costa LO. Effectiveness of the back school and mckenzie techniques in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Aug 5;12:179. doi: 10.1186/1471-2474-12-179.
PMID: 21819594
responsible party type: Principal Investigator
investigator affiliation: Escola Superior de Tecnologia da Saúde do Porto
investigator full name: Natália Maria Oliveira Campelo
investigator title: professor