<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/NCT04475770</url>
  </required_header>
  <id_info>
    <org_study_id>2</org_study_id>
    <nct_id>NCT04475770</nct_id>
  </id_info>
  <brief_title>Effect of SNAGs on Stiffness of Lumbar Stabilizer Muscles</brief_title>
  <official_title>Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Non-specific Low Back Pain Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istinye University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istinye University</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>
      Low back pain is a common health problem worldwide. Epidemiological studies have shown that&#xD;
      70-80% of all people are affected at least once in their lifetime. Although it is common,&#xD;
      often the cause of the pain has not been determined and is called 'nonspecific low back pain.&#xD;
&#xD;
      Low back pain has been shown to alter the structure of deep and superficial muscles such as&#xD;
      multifidus and erector spinae. However, it has not been fully explained how changes in muscle&#xD;
      fiber structure affect the biomechanical properties and functions of the muscle.&#xD;
&#xD;
      There are various manual therapy techniques in the treatment of low back pain. Manual&#xD;
      therapists use treatment modalities that include passive techniques such as mobilization and&#xD;
      manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a&#xD;
      sustained transverse glide to the spinous process of a vertebra while actively or passively&#xD;
      performing. These techniques have gained the name &quot;Sustained Natural Apophyseal Glides&quot;&#xD;
      (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal&#xD;
      joints under treatment.&#xD;
&#xD;
      Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively&#xD;
      assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency&#xD;
      ultrasound waves.&#xD;
&#xD;
      The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness&#xD;
      of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>muscle stiffness</measure>
    <time_frame>4 weeks</time_frame>
    <description>The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The sit and reach test</measure>
    <time_frame>4 weeks</time_frame>
    <description>The sit and reach test will be used for back and leg flexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pain will be measured with Visual Analogue Scale. Visual Analogue Scale is the most commonly used method for measuring the pain level.&#xD;
It is scored between 0 and 10. 0 means no pain (minimum score) 10 means I have unbearable pain (maximum score). Higher score means worse result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Functional Reach Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Functional Reach Test will be used to measure standing balance. While the contact surface of the person was in contact with the ground, the distance between the length of the arm and its maximum reach will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Flamingo Balance Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Flamingo Balance Test is total body balance test, and forms part of the Eurofit Testing Battery. This single leg balance test assesses the strength of the leg, pelvic, and trunk muscle as well as dynamic balance. purpose: To assess the ability to balance successfully on a single leg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateral bridge test</measure>
    <time_frame>4 weeks</time_frame>
    <description>side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk extensor endurance</measure>
    <time_frame>4 weeks</time_frame>
    <description>The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Oswestry Disability Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>The functional level will be assessed using The Oswestry Disability Index (ODI) that ıs consist of 10-item. These items assessed pain intensity, personal care, lifting, walking, sitting, sleeping, sex life, and social life. Each item is numbered between from 0 to 5. As the total score increases, the level of disability increases. Each item is number between 0 to 5. As the total score increases, the level of disability increases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Manuel Therapy</condition>
  <arm_group>
    <arm_group_label>Real SNAGs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Real SNAGs group consists of 16 participants, where the Mulligan concept lumbal SNAGs is applied and evaluations are made before and after.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham SNAGs</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Sham SNAGs group consists of 16 participants who performed the same positioning as the Real SNAGs group and evaluated twice with a similar interval without any intervention to the spine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Real Sustained Natural Apophyseal Glides (SNAGS)</intervention_name>
    <description>Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name &quot;Sustained Natural Apophyseal Glides&quot; (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.</description>
    <arm_group_label>Real SNAGs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Sustained Natural Apophyseal Glides (SNAGS)</intervention_name>
    <description>The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.</description>
    <arm_group_label>Sham SNAGs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who diagnosed with non-specific low back pain&#xD;
&#xD;
          -  between the ages of 18-24&#xD;
&#xD;
          -  patients who able to perform at least 40° of trunk flexion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who obese, pregnant, had specific low back pain&#xD;
&#xD;
          -  indication for surgery in the past 1 year&#xD;
&#xD;
          -  the trauma of lumbar region, and systemic inflammatory disease affecting this area&#xD;
&#xD;
          -  exercise and conventional physiotherapy in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istinye University</name>
      <address>
        <city>Istanbul</city>
        <state>Eyalet/Yerleşke</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>September 15, 2022</last_update_submitted>
  <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istinye University</investigator_affiliation>
    <investigator_full_name>Yunus Emre Tutuneken</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04475770
org study id: 2
nct id: NCT04475770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low back pain is a common health problem worldwide. Epidemiological studies have shown that
      70-80% of all people are affected at least once in their lifetime. Although it is common,
      often the cause of the pain has not been determined and is called 'nonspecific low back pain.

      Low back pain has been shown to alter the structure of deep and superficial muscles such as
      multifidus and erector spinae. However, it has not been fully explained how changes in muscle
      fiber structure affect the biomechanical properties and functions of the muscle.

      There are various manual therapy techniques in the treatment of low back pain. Manual
      therapists use treatment modalities that include passive techniques such as mobilization and
      manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a
      sustained transverse glide to the spinous process of a vertebra while actively or passively
      performing. These techniques have gained the name "Sustained Natural Apophyseal Glides"
      (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal
      joints under treatment.

      Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively
      assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency
      ultrasound waves.

      The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness
      of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment
      technique.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: muscle stiffness
time frame: 4 weeks
description: The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.
measure: The sit and reach test
time frame: 4 weeks
description: The sit and reach test will be used for back and leg flexibility.
measure: Visual Analogue Scale
time frame: 4 weeks
description: Pain will be measured with Visual Analogue Scale. Visual Analogue Scale is the most commonly used method for measuring the pain level.
It is scored between 0 and 10. 0 means no pain (minimum score) 10 means I have unbearable pain (maximum score). Higher score means worse result.
measure: The Functional Reach Test
time frame: 4 weeks
description: The Functional Reach Test will be used to measure standing balance. While the contact surface of the person was in contact with the ground, the distance between the length of the arm and its maximum reach will be measured.
measure: The Flamingo Balance Test
time frame: 4 weeks
description: The Flamingo Balance Test is total body balance test, and forms part of the Eurofit Testing Battery. This single leg balance test assesses the strength of the leg, pelvic, and trunk muscle as well as dynamic balance. purpose: To assess the ability to balance successfully on a single leg.
measure: Lateral bridge test
time frame: 4 weeks
description: side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine.
measure: Trunk extensor endurance
time frame: 4 weeks
description: The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine.
measure: The Oswestry Disability Index
time frame: 4 weeks
description: The functional level will be assessed using The Oswestry Disability Index (ODI) that ıs consist of 10-item. These items assessed pain intensity, personal care, lifting, walking, sitting, sleeping, sex life, and social life. Each item is numbered between from 0 to 5. As the total score increases, the level of disability increases. Each item is number between 0 to 5. As the total score increases, the level of disability increases.
arm group label: Real SNAGs
arm group type: Experimental
description: Real SNAGs group consists of 16 participants, where the Mulligan concept lumbal SNAGs is applied and evaluations are made before and after.
arm group label: Sham SNAGs
arm group type: Sham Comparator
description: The Sham SNAGs group consists of 16 participants who performed the same positioning as the Real SNAGs group and evaluated twice with a similar interval without any intervention to the spine.
intervention type: Other
intervention name: Real Sustained Natural Apophyseal Glides (SNAGS)
description: Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.
arm group label: Real SNAGs
intervention type: Other
intervention name: Sham Sustained Natural Apophyseal Glides (SNAGS)
description: The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.
arm group label: Sham SNAGs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istinye University
investigator full name: Yunus Emre Tutuneken
investigator title: Research assistant
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No