xml: <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/NCT05996341</url>
    </required_header>
    <id_info>
      <org_study_id>CMUH111-REC2-221</org_study_id>
      <nct_id>NCT05996341</nct_id>
    </id_info>
    <brief_title>The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain</brief_title>
    <official_title>The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China Medical University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China Medical University Hospital</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>
        The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal&#xD;
        wall and also known as a significant component of core stability. Abdominal draw-in maneuver&#xD;
        (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation&#xD;
        of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with&#xD;
        low intensity exercise that produces similar results to high intensity training. Therefore,&#xD;
        the purpose of this study is to explore whether BFR-assisted ADIM can become a new auxiliary&#xD;
        way to train TrA, and whether it can better activate their TrA in patients with low back&#xD;
        pain. Low back pain (LBP) is a major health problem with huge economic and social costs. Core&#xD;
        muscle weakness is a risk factor for LBP. Past studies have also pointed out that the biggest&#xD;
        cause affecting the quality of life and activities of modern people is lower back pain. In&#xD;
        modern life, low back pain can be said to be a very common disease. According to past&#xD;
        research, there is a 50% to 70% chance that people may have lower back pain in their&#xD;
        lifetime, and non-specific low back pain accounts for the majority (90%), the reason why the&#xD;
        influence of non-specific low back pain is so great is not only physically but also&#xD;
        psychologically. When people perform many functions of daily life, people need the help of&#xD;
        the waist. But once the wrong way of effort or posture will lead to more pressure on the&#xD;
        spine, leading to greater pain, a strong sense of discomfort will haunt them for a long time.&#xD;
        Therefore, the activation and control of TrA is very important because of the relationship&#xD;
        between the lateral direction of TrA, so when TrA contracts, it will result in a decrease in&#xD;
        waist circumference, an increase in thoracolumbar fascia tension and an increase in&#xD;
        intra-abdominal pressure, so it is regarded as the most important stable muscle in the&#xD;
        core.In addition, TrA is a special presence in the core muscle group, it can independently&#xD;
        contract and like the presence of waist protection to stabilize our spine, but because it is&#xD;
        located in the deepest layer, coupled with less muscle activity, it is difficult to&#xD;
        effectively activate correctly, so if TrA is not activated or contracted correctly, it may&#xD;
        cause non-specific lower back pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 20 healthy people and 20 patients with lower back pain were recruited and&#xD;
        divided into healthy group, experimental group (patients with lower back pain) and sham&#xD;
        experimental group (patients with lower back pain). The subjects in the experimental group&#xD;
        and the healthy group were tied under the ribs with a pulse band (14 cm wide and 84 cm long)&#xD;
        to block at least 60% of the blood flow and do abdominal exercise. In the sham experimental&#xD;
        group, the ventral compression band was fastened but the abdominal contraction exercise was&#xD;
        performed without inflation. Each subject exercised for 20 minutes twice a week for six&#xD;
        weeks. At the first, third and sixth week, ultrasound (Ultrasound, USD) was used to evaluate&#xD;
        the muscle thickness and muscle activation of external oblique muscle, internal oblique&#xD;
        muscle and transverse muscle (core muscle group). This study expects that blood blocking&#xD;
        training can increase the degree of activation, muscle strength and hypertrophy of transverse&#xD;
        abdominal muscle in patients with lower back pain, and can provide a new auxiliary method to&#xD;
        improve the predicament that it is difficult to activate transverse abdominal muscle&#xD;
        correctly.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Muscle thickness</measure>
      <time_frame>The experiment was conducted for a total of five weeks.After the first ultrasonic image estimation and the fourth week, all the assessments are carried out again, and then tracked down in the fifth week. Estimate.</time_frame>
      <description>In this study, abdominal muscles were evaluated by Brightness-mode, 5M-Hz, Linear).&#xD;
  The thickness of meat during abdominal muscle relaxation and during draw-in. The probing position is located at the lowest end of the rib and in the middle of the iliac spine.&#xD;
  At the midpoint of the axillary line. Put an ultrasonic image of the abdominal muscle in the abdominal muscle and vomit in ADIM.&#xD;
  At the end of the day, we take an image. Then calculate the muscle thickness. The calculation standard is from the tail and abdomen of TrA The fascia joint tip is three centimeters inward, and the muscle thickness of transvers abdominal, internal oblique and external oblique muscle is calculated from bottom to top, and Total muscle thickness, measured in centimeters (cm).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Non-specific Low Back Pain</condition>
    <arm_group>
      <arm_group_label>LBPADIM_BFR group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Recipient No. 12 lower ribs and upper rechargeable nylon ribs , charge to 160mmHg and do ADIM at the same time and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.&#xD;
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LBPADIM_shan BFR group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The recipient has a rechargeable nylon rib under the 12th rib , but it is not filled and does not cause abdominal muscle BFR, which is used as the BFR of abdominal muscle.&#xD;
  At the same time, we also do ADIM authentication,and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.&#xD;
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HealthyADIM_BFR group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Tested The top rechargeable nylon under the 12th rib , charge to 160mmHg and do ADIM password at the same time, and tand retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.&#xD;
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>blood flow restriction</intervention_name>
      <description>12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg</description>
      <arm_group_label>HealthyADIM_BFR group</arm_group_label>
      <arm_group_label>LBPADIM_BFR group</arm_group_label>
      <arm_group_label>LBPADIM_shan BFR group</arm_group_label>
      <other_name>Delfi's Personalized Tourniquet System</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirm that it is caused by pathological and mental stress or illness&#xD;
  &#xD;
            -  Non-idiopathic low back pain&#xD;
  &#xD;
            -  persistent or intermittent pain for more than six weeks&#xD;
  &#xD;
            -  the pain index of the scale, number is between 2 and 10 points.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Stress fracture&#xD;
  &#xD;
            -  osteoporosis&#xD;
  &#xD;
            -  acute lower back pain&#xD;
  &#xD;
            -  Spinal tumor&#xD;
  &#xD;
            -  spinal canal narrowing&#xD;
  &#xD;
            -  spinal osteitis&#xD;
  &#xD;
            -  spinal meningitis&#xD;
  &#xD;
            -  vertebral slippage&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yueh-Ling Hsieh</last_name>
      <phone>04-22053366</phone>
      <phone_ext>#7312</phone_ext>
      <email>sherrie@mail.cmu.edu.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>yan-zhang Li</last_name>
      <phone>0917805895</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Physical Therapy of China Medical University</name>
        <address>
          <city>Taichung</city>
          <state>Test2</state>
          <zip>test3</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yueh-Ling Hsieh, PHD</last_name>
        <phone>04-22053366</phone>
        <phone_ext>7312</phone_ext>
        <email>sherrie@mail.cmu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>
  
  
text: 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/NCT05996341
  org study id: CMUH111-REC2-221
  nct id: NCT05996341
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal
        wall and also known as a significant component of core stability. Abdominal draw-in maneuver
        (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation
        of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with
        low intensity exercise that produces similar results to high intensity training. Therefore,
        the purpose of this study is to explore whether BFR-assisted ADIM can become a new auxiliary
        way to train TrA, and whether it can better activate their TrA in patients with low back
        pain. Low back pain (LBP) is a major health problem with huge economic and social costs. Core
        muscle weakness is a risk factor for LBP. Past studies have also pointed out that the biggest
        cause affecting the quality of life and activities of modern people is lower back pain. In
        modern life, low back pain can be said to be a very common disease. According to past
        research, there is a 50% to 70% chance that people may have lower back pain in their
        lifetime, and non-specific low back pain accounts for the majority (90%), the reason why the
        influence of non-specific low back pain is so great is not only physically but also
        psychologically. When people perform many functions of daily life, people need the help of
        the waist. But once the wrong way of effort or posture will lead to more pressure on the
        spine, leading to greater pain, a strong sense of discomfort will haunt them for a long time.
        Therefore, the activation and control of TrA is very important because of the relationship
        between the lateral direction of TrA, so when TrA contracts, it will result in a decrease in
        waist circumference, an increase in thoracolumbar fascia tension and an increase in
        intra-abdominal pressure, so it is regarded as the most important stable muscle in the
        core.In addition, TrA is a special presence in the core muscle group, it can independently
        contract and like the presence of waist protection to stabilize our spine, but because it is
        located in the deepest layer, coupled with less muscle activity, it is difficult to
        effectively activate correctly, so if TrA is not activated or contracted correctly, it may
        cause non-specific lower back pain.
  In this study, 20 healthy people and 20 patients with lower back pain were recruited and
        divided into healthy group, experimental group (patients with lower back pain) and sham
        experimental group (patients with lower back pain). The subjects in the experimental group
        and the healthy group were tied under the ribs with a pulse band (14 cm wide and 84 cm long)
        to block at least 60% of the blood flow and do abdominal exercise. In the sham experimental
        group, the ventral compression band was fastened but the abdominal contraction exercise was
        performed without inflation. Each subject exercised for 20 minutes twice a week for six
        weeks. At the first, third and sixth week, ultrasound (Ultrasound, USD) was used to evaluate
        the muscle thickness and muscle activation of external oblique muscle, internal oblique
        muscle and transverse muscle (core muscle group). This study expects that blood blocking
        training can increase the degree of activation, muscle strength and hypertrophy of transverse
        abdominal muscle in patients with lower back pain, and can provide a new auxiliary method to
        improve the predicament that it is difficult to activate transverse abdominal muscle
        correctly.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Muscle thickness
  time frame: The experiment was conducted for a total of five weeks.After the first ultrasonic image estimation and the fourth week, all the assessments are carried out again, and then tracked down in the fifth week. Estimate.
  description: In this study, abdominal muscles were evaluated by Brightness-mode, 5M-Hz, Linear).
  The thickness of meat during abdominal muscle relaxation and during draw-in. The probing position is located at the lowest end of the rib and in the middle of the iliac spine.
  At the midpoint of the axillary line. Put an ultrasonic image of the abdominal muscle in the abdominal muscle and vomit in ADIM.
  At the end of the day, we take an image. Then calculate the muscle thickness. The calculation standard is from the tail and abdomen of TrA The fascia joint tip is three centimeters inward, and the muscle thickness of transvers abdominal, internal oblique and external oblique muscle is calculated from bottom to top, and Total muscle thickness, measured in centimeters (cm).
  arm group label: LBPADIM_BFR group
  arm group type: Experimental
  description: Recipient No. 12 lower ribs and upper rechargeable nylon ribs , charge to 160mmHg and do ADIM at the same time and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
  arm group label: LBPADIM_shan BFR group
  arm group type: Placebo Comparator
  description: The recipient has a rechargeable nylon rib under the 12th rib , but it is not filled and does not cause abdominal muscle BFR, which is used as the BFR of abdominal muscle.
  At the same time, we also do ADIM authentication,and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
  arm group label: HealthyADIM_BFR group
  arm group type: Experimental
  description: Tested The top rechargeable nylon under the 12th rib , charge to 160mmHg and do ADIM password at the same time, and tand retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once.
  The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
  intervention type: Device
  intervention name: blood flow restriction
  description: 12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg
  arm group label: HealthyADIM_BFR group
  arm group label: LBPADIM_BFR group
  arm group label: LBPADIM_shan BFR group
  other name: Delfi's Personalized Tourniquet System
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yueh-Ling Hsieh
  phone: 04-22053366
  phone ext: #7312
  email: sherrie@mail.cmu.edu.tw
  last name: yan-zhang Li
  phone: 0917805895
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Back Pain
  mesh term: Low Back Pain