<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/NCT02200913</url>
  </required_header>
  <id_info>
    <org_study_id>WYodchaisarn</org_study_id>
    <nct_id>NCT02200913</nct_id>
  </id_info>
  <brief_title>Effects of Core Stabilization Exercise on Balance</brief_title>
  <official_title>Effects of Core Stabilization Exercise on Balance in Low Back Pain Patients With Clinical Lumbar Instability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent studies indicate that patients with chronic low back pain (LBP) present problems in&#xD;
      balance. Alterations in proprioception are the possible causes of alteration of postural&#xD;
      balance in LBP.&#xD;
&#xD;
      Previous studies reported an improvement of CSE on joint mobility, pain, functional&#xD;
      disability, and trunk muscle activation pattern in patients with clinical lumbar instability&#xD;
      (CLI); however, it was an immediate effect. However, previous studies did not report indirect&#xD;
      effect may occur in CLI as postural balance and other kinds of exercise as strengthening in&#xD;
      CLI. The general trunk strengthening exercise is common used in physical therapy clinic on&#xD;
      LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge,&#xD;
      the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of&#xD;
      balance.&#xD;
&#xD;
      The present study will conduct to fill the gaps of previous studies which will provide&#xD;
      immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity&#xD;
      and ratio activation of trunk muscles and included blinding process of the assessor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) is the most common musculoskeletal complaint. In most LBPs, it is benign&#xD;
      and disappears within six weeks, but approximately 20% of individuals with LBP do not show&#xD;
      any improvement in their condition, which may progress to chronic low back pain. LBP not only&#xD;
      interferes with biomechanical change, but also causes ability to work leading to reduced&#xD;
      productivity, economic burden to individuals and society for medical costs Recent studies&#xD;
      indicate that patients with chronic low back pain present diminished postural control,&#xD;
      manifesting problems in balance. Postural balance is controlled by sensory information,&#xD;
      central processing and neuromuscular responses. Alterations in proprioception are the&#xD;
      possible causes of alteration of postural balance in individuals with low back pain.&#xD;
&#xD;
      For clinical studies using core stabilization exercise (CSE) as treatment have revealed&#xD;
      conflicting findings on pain, functional disability and muscle responses in chronic LBP. The&#xD;
      few studies that investigated CSE as an isolated factor. Kumar (2011) reported an improvement&#xD;
      of CSE on joint mobility and pain pressure threshold in patients with clinical lumbar&#xD;
      instability; however, it was an immediate effect of CSE and blinding process was not&#xD;
      performed. However, an effectiveness of CSE on pain intensity, functional disability, and&#xD;
      trunk muscle activation pattern were improved in clinical lumbar instability (CLI). In&#xD;
      addition, after 10-week CSE provides greater training and retention effects on pain-related&#xD;
      outcomes and induced activation of deep abdominal muscles in CLI compared with conventional&#xD;
      treatment (stretching exercise and hot pack). However, previous studies did not report&#xD;
      indirect effect may occur in CLI as postural balance and other kinds of exercise as&#xD;
      strengthening in CLI. The general trunk strengthening exercise is common used in physical&#xD;
      therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To&#xD;
      our knowledge, the usefulness of CSE technique as abdominal drawing-in maneuver (ADIM) has&#xD;
      not yet been investigated in CLI patients with outcome measure of balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>center of pressure</measure>
    <time_frame>up to 3-months after the last intervention session</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lumbar Spine Instability</condition>
  <arm_group>
    <arm_group_label>core stabilization exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>core stabilization exercise 2 times/week 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general trunk strengthening exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>general trunk strengthening exercise, 2 times/week, 10 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>core stabilization exercise</intervention_name>
    <description>core stabilization exercise, 2 times/week, 10 weeks</description>
    <arm_group_label>general trunk strengthening exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>general trunk strengthening exercise</intervention_name>
    <description>general trunk strengthening exercise, 2 times/week, 10 weeks</description>
    <arm_group_label>core stabilization exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  aged between 20-60 years&#xD;
&#xD;
          -  low back pain (LBP) with or without radiating leg pain for period of at least 12 weeks&#xD;
&#xD;
          -  answer 'yes' at least seven items of questionnaire&#xD;
&#xD;
          -  present positive sign of the aberrant movement sign&#xD;
&#xD;
          -  Present at least one positive sign from painful catch , prone instability catch test,&#xD;
             or apprehension symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be pregnant.&#xD;
&#xD;
          -  Have serious spinal pathology: spinal fracture, spinal malignancy or spinal infection&#xD;
&#xD;
          -  Have quada equina syndrome&#xD;
&#xD;
          -  Have neurological deficit (at least 2 of the following signs: weakness of lower limbs&#xD;
             (muscle power &lt; grade 3 using manual muscle test), reflex changes, or abnormality or&#xD;
             loss of sensation of lower limbs associated with the spinal nerve root&#xD;
&#xD;
          -  Have obvious abnormal movement of the lumbar motion segment when assessed by&#xD;
             flexion-extension radiographs: sagittal plane translation larger than 4.5mm or 15&#xD;
             percent of vertebral body width according to other vertebral segment, or sagittal&#xD;
             plane rotation larger than 15 degrees at L1-L2, L2-L3 or L3-L4, 20 degrees at L4-L5 or&#xD;
             25 degrees at L5-S1&#xD;
&#xD;
          -  Have visual disorder, vestibular disorder, neuromuscular diseases such as&#xD;
             polyneuropathy, or diabetes neuropathy&#xD;
&#xD;
          -  Participate in their intervention less than 5 out of the 10 week of intervention.&#xD;
&#xD;
          -  Regularly treat with core stabilization exercise (CSE), or trunk strengthen exercises.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wantanee Yodchaisarn, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Center in Back, Neck, Other Joint Pain and Human Performance</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Puntumetakul R, Areeudomwong P, Emasithi A, Yamauchi J. Effect of 10-week core stabilization exercise training and detraining on pain-related outcomes in patients with clinical lumbar instability. Patient Prefer Adherence. 2013 Nov 19;7:1189-99. doi: 10.2147/PPA.S50436. eCollection 2013.</citation>
    <PMID>24399870</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Wantanee Yodchaisarn</investigator_full_name>
    <investigator_title>Research Center in Back, Neck, Other Joint Pain and Human Performance</investigator_title>
  </responsible_party>
  <!-- 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/NCT02200913
org study id: WYodchaisarn
nct id: NCT02200913
lead sponsor: 
has dmc: Yes
Recent studies indicate that patients with chronic low back pain (LBP) present problems in
      balance. Alterations in proprioception are the possible causes of alteration of postural
      balance in LBP.

      Previous studies reported an improvement of CSE on joint mobility, pain, functional
      disability, and trunk muscle activation pattern in patients with clinical lumbar instability
      (CLI); however, it was an immediate effect. However, previous studies did not report indirect
      effect may occur in CLI as postural balance and other kinds of exercise as strengthening in
      CLI. The general trunk strengthening exercise is common used in physical therapy clinic on
      LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge,
      the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of
      balance.

      The present study will conduct to fill the gaps of previous studies which will provide
      immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity
      and ratio activation of trunk muscles and included blinding process of the assessor.
Low back pain (LBP) is the most common musculoskeletal complaint. In most LBPs, it is benign
      and disappears within six weeks, but approximately 20% of individuals with LBP do not show
      any improvement in their condition, which may progress to chronic low back pain. LBP not only
      interferes with biomechanical change, but also causes ability to work leading to reduced
      productivity, economic burden to individuals and society for medical costs Recent studies
      indicate that patients with chronic low back pain present diminished postural control,
      manifesting problems in balance. Postural balance is controlled by sensory information,
      central processing and neuromuscular responses. Alterations in proprioception are the
      possible causes of alteration of postural balance in individuals with low back pain.

      For clinical studies using core stabilization exercise (CSE) as treatment have revealed
      conflicting findings on pain, functional disability and muscle responses in chronic LBP. The
      few studies that investigated CSE as an isolated factor. Kumar (2011) reported an improvement
      of CSE on joint mobility and pain pressure threshold in patients with clinical lumbar
      instability; however, it was an immediate effect of CSE and blinding process was not
      performed. However, an effectiveness of CSE on pain intensity, functional disability, and
      trunk muscle activation pattern were improved in clinical lumbar instability (CLI). In
      addition, after 10-week CSE provides greater training and retention effects on pain-related
      outcomes and induced activation of deep abdominal muscles in CLI compared with conventional
      treatment (stretching exercise and hot pack). However, previous studies did not report
      indirect effect may occur in CLI as postural balance and other kinds of exercise as
      strengthening in CLI. The general trunk strengthening exercise is common used in physical
      therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To
      our knowledge, the usefulness of CSE technique as abdominal drawing-in maneuver (ADIM) has
      not yet been investigated in CLI patients with outcome measure of balance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: center of pressure
time frame: up to 3-months after the last intervention session
arm group label: core stabilization exercise
arm group type: Experimental
description: core stabilization exercise 2 times/week 10 weeks
arm group label: general trunk strengthening exercise
arm group type: Experimental
description: general trunk strengthening exercise, 2 times/week, 10 weeks
intervention type: Other
intervention name: core stabilization exercise
description: core stabilization exercise, 2 times/week, 10 weeks
arm group label: general trunk strengthening exercise
intervention type: Other
intervention name: general trunk strengthening exercise
description: general trunk strengthening exercise, 2 times/week, 10 weeks
arm group label: core stabilization exercise
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wantanee Yodchaisarn, M.Sc.
role: Principal Investigator
affiliation: Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
facility: 
country: Thailand
citation: Puntumetakul R, Areeudomwong P, Emasithi A, Yamauchi J. Effect of 10-week core stabilization exercise training and detraining on pain-related outcomes in patients with clinical lumbar instability. Patient Prefer Adherence. 2013 Nov 19;7:1189-99. doi: 10.2147/PPA.S50436. eCollection 2013.
PMID: 24399870
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Wantanee Yodchaisarn
investigator title: Research Center in Back, Neck, Other Joint Pain and Human Performance