<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/NCT02222935</url>
  </required_header>
  <id_info>
    <org_study_id>PSG02</org_study_id>
    <nct_id>NCT02222935</nct_id>
  </id_info>
  <brief_title>Effectiveness of Balance Training in Chronic Low Back Pain Patients</brief_title>
  <acronym>CLB</acronym>
  <official_title>Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskaran Chandrasekaran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PSG Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Balance problems are addressed in low back pain patients. Dearth of literature available to&#xD;
      prove core strengthening or any form of back exercises improving functional outcomes or&#xD;
      balance in chronic back pain patients. No studies focus on balance training in improving&#xD;
      balance of low back pain patients. The authors are conducting a randomised trial comparing&#xD;
      balance exercises and routine back exercise program in improving pain, functional outcomes&#xD;
      and balance of the patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Balance deficits are common in low back pain. Current literature fail to prove&#xD;
      the effectiveness of routine back exercises in improving balance of back pain patients. No&#xD;
      study has concentrated on balance training in back pain patients.&#xD;
&#xD;
      Objective: Compare balance exercises and routine back exercises in improving balance and&#xD;
      other functional outcomes.&#xD;
&#xD;
      Procedure: Back pain patients attending physiotherapy department of tertiary care teaching&#xD;
      hospitals will be recruited voluntarily. Randomised to either balance and routine program&#xD;
      based on simple lottery method. Balance training comprises of 5 exercises - single leg&#xD;
      squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back&#xD;
      exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral&#xD;
      planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star&#xD;
      Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and&#xD;
      post 2 weeks outcome scores will be analysed through paired and unpaired for between and&#xD;
      within groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Early Phase 1</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Starr Edward Balance Test</measure>
    <time_frame>Baseline, 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Baseline, 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue score</measure>
    <time_frame>Baseline, 2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Balance exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Back exercise Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance Exercise Training</intervention_name>
    <description>Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks</description>
    <arm_group_label>Balance exercise training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine Back exercise program</intervention_name>
    <description>Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks</description>
    <arm_group_label>Routine Back exercise Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non specific low back pain diagnosed by orthopedical surgeon or physiatrist&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Age 25 - 45 years (to avoid age related balance deficit)&#xD;
&#xD;
          -  Should have balance deficit percentage (&gt; 20%) through balance assessment scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  H/O Benign Paroxysmal Positional Vertigo&#xD;
&#xD;
          -  Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance&#xD;
&#xD;
          -  any form of ear infection&#xD;
&#xD;
          -  Recent ear, nose, throat surgery&#xD;
&#xD;
          -  Recent surgery in abdomen, thorax, head (&lt; 2 years)&#xD;
&#xD;
          -  Recent lower limb surgeries, injuries (&lt; 6 months)&#xD;
&#xD;
          -  Any form of walking aids (cane, walker)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pavita Devi, BPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Physiotherapist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Baskaran Chandrasekaran, MPT</last_name>
    <role>Study Chair</role>
    <affiliation>Senior Physiotherapist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sumathi Muraleetharan, BPT</last_name>
    <role>Study Chair</role>
    <affiliation>Senior Physiotherpist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ramamoorthy V Dr, MD PMR</last_name>
    <role>Study Director</role>
    <affiliation>Head of The Department, PMR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PSG Hospitals, Department of Physical Medicine Rehabilitation</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamilnadu</state>
        <zip>641004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>PSG Hospitals</investigator_affiliation>
    <investigator_full_name>Baskaran Chandrasekaran</investigator_full_name>
    <investigator_title>Senior Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Balance training</keyword>
  <keyword>low back pain</keyword>
  <keyword>balance test</keyword>
  <keyword>routine back exercise</keyword>
  <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>


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/NCT02222935
org study id: PSG02
nct id: NCT02222935
lead sponsor: 
has dmc: Yes
Balance problems are addressed in low back pain patients. Dearth of literature available to
      prove core strengthening or any form of back exercises improving functional outcomes or
      balance in chronic back pain patients. No studies focus on balance training in improving
      balance of low back pain patients. The authors are conducting a randomised trial comparing
      balance exercises and routine back exercise program in improving pain, functional outcomes
      and balance of the patients
Background: Balance deficits are common in low back pain. Current literature fail to prove
      the effectiveness of routine back exercises in improving balance of back pain patients. No
      study has concentrated on balance training in back pain patients.

      Objective: Compare balance exercises and routine back exercises in improving balance and
      other functional outcomes.

      Procedure: Back pain patients attending physiotherapy department of tertiary care teaching
      hospitals will be recruited voluntarily. Randomised to either balance and routine program
      based on simple lottery method. Balance training comprises of 5 exercises - single leg
      squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back
      exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral
      planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star
      Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and
      post 2 weeks outcome scores will be analysed through paired and unpaired for between and
      within groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Starr Edward Balance Test
time frame: Baseline, 2 weeks
measure: Berg Balance Scale
time frame: Baseline, 2 weeks
measure: Visual Analogue score
time frame: Baseline, 2 weeks
arm group label: Balance exercise training
arm group type: Experimental
description: Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
arm group label: Routine Back exercise Program
arm group type: Active Comparator
description: Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
intervention type: Behavioral
intervention name: Balance Exercise Training
description: Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks
arm group label: Balance exercise training
intervention type: Behavioral
intervention name: Routine Back exercise program
description: Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks
arm group label: Routine Back exercise Program
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
last name: Pavita Devi, BPT
role: Principal Investigator
affiliation: Senior Physiotherapist
last name: Baskaran Chandrasekaran, MPT
role: Study Chair
affiliation: Senior Physiotherapist
last name: Sumathi Muraleetharan, BPT
role: Study Chair
affiliation: Senior Physiotherpist
last name: Ramamoorthy V Dr, MD PMR
role: Study Director
affiliation: Head of The Department, PMR
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: PSG Hospitals
investigator full name: Baskaran Chandrasekaran
investigator title: Senior Physiotherapist
mesh term: Back Pain
mesh term: Low Back Pain