<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/NCT03016676</url>
  </required_header>
  <id_info>
    <org_study_id>LPU-11304873</org_study_id>
    <nct_id>NCT03016676</nct_id>
  </id_info>
  <brief_title>Efficacy of SM on Postural Instability and Quality of Life in Patients With Chronic Non Specific Low Back Pain(CNSLBP)</brief_title>
  <official_title>Study of Spinal Manipulation(SM) Decrease Postural Instability and Improve Quality of Life in Patients With Chronic Non Specific Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lovely Professional University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lovely Professional University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will give a new insight to the physiotherapy fraternity in the effects of spinal&#xD;
      manipulation in as clinical practice, as well as the patient's community in quick&#xD;
      re-establishment of functional ability, pain decrease, and improvement of quality of life for&#xD;
      economic reasons. In this high opinion, application of short-term intensive spinal&#xD;
      manipulation for non specific chronic low back pain treatment is desirable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol for group A included High velocity low amplitude thrust (HVLA) to the lumbar&#xD;
      region of the spine between L1 and L5 vertebrae.The HVLA thrust will be performed with the&#xD;
      patient side lying in a neutral.52 They take part in 12 treatment visits, 10 to 20 minutes&#xD;
      sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle&#xD;
      stretching, and ischemic compression of tender points) may be used as needed to facilitate&#xD;
      the manual therapy.&#xD;
&#xD;
      The protocol for group B included sets of exercise therapy. There are three components to the&#xD;
      exercise therapy (ET) program: self education, supervised exercise visits, and home exercise.&#xD;
      The overall objectives are to help patient's manage their LBP and prevent future LBP&#xD;
      recurrences. Total number of visits 12 (e.g., ability to perform exercises independently).&#xD;
&#xD;
      Outcome:&#xD;
&#xD;
      Patient self-report outcomes will be collected at first baseline visit and its base on the&#xD;
      pain intensity and quality of life will be assessed by using numerical pain rating scale and&#xD;
      EuroQol questionnaire. Objective outcome measures will be collected at the first baseline&#xD;
      visit and its base on postural instability and pressure pain threshold will be assessed by&#xD;
      using Win track platform and digital algometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.</measure>
    <time_frame>Baseline before treatment and after 2 week of treatment</time_frame>
    <description>Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study,Change from baseline in postural instability will be measured by Win Track Platform at 2 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.</measure>
    <time_frame>Baseline before treatment and after 2 week of treatment</time_frame>
    <description>Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in quality of life on EuroQoL questionnaire at 2 weeks.EuroQol questionnaire is a wide accepted questionnaire for health-related quality of life and consists of two components. Its first component (EQ-5D-5L) consists of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.</measure>
    <time_frame>Baseline before treatment and after 2 week of treatment</time_frame>
    <description>Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain instability on Numerical pain rating scale (NPRS). An11-point numeric pain rating scale will be used to assess pain intensity (primary outcome measure), with 0 representing &quot;no pain&quot; and 10 representing the &quot;worst possible pain&quot; at the time of the assessment. Pain intensity will be measured before and after treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients with CNSLBP will be received SM and ET to measure Pain sensitivity(Pressure pain threshold-PPT) to assess after 12 session over 2 weeks.</measure>
    <time_frame>Baseline before treatment and treatment after 2 week of treatment</time_frame>
    <description>Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain sensitivity (PPT) on Digital algometer.Pain sensitivity (PPT) will be measured on the lumbar area bilaterally. Digital Algometer (Jagson scientific Industries, Ambala-133001, Haryana, India) will be used with a circular rounded aluminium tip, 1 cm2, and with an application rate of 25 KN/s. The measurements will be performed twice and the average of the two registrations will be filed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Chronic Non Specific Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Spinal manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal manipulation -High velocity low amplitude thrust (HVLA), Dosages : 2 repetition at the same time, Duration-10-20 minutes. total 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise Therapy(ET): Exercise therapy (ET) 3 program: self education, supervised exercise visits, and home exercise. Duration-45 minutes,Total number of visits 12 for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal Manipulation</intervention_name>
    <description>High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae. The exact level thrust will be at the discretion of the treating practitioner determined by the level with the greatest perceivable motion restriction. The HVLA thrust will be performed with the patient side lying in a neutral.They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.</description>
    <arm_group_label>Spinal manipulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise therapy</intervention_name>
    <description>Self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's mange their LBP and prevent future LBP recurrences. Total number of visits 12.Each visit starts with 10 minutes of self-care education to help patients establish and monitor goals aligned with the exercise program and enhance their understanding of LBP. Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).</description>
    <arm_group_label>Exercise therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 55 years of age.&#xD;
&#xD;
          -  Both genders.&#xD;
&#xD;
          -  Subjects diagnosed with non-specific chronic low back pain with duration of &gt;3 months.&#xD;
&#xD;
          -  Low back pain intensity≥3 on 0-10 in numerical pain rating scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury or surgery of spine.&#xD;
&#xD;
          -  Congenital spinal deformity (e.g Spina bifida, Scoliosis, ankylosing spondylitis etc )&#xD;
&#xD;
          -  Lumbar radiculopathy or presenting neurological deficit.&#xD;
&#xD;
          -  Subjects administered Epidural injection.&#xD;
&#xD;
          -  Contra-indication to manipulations-vertebral malignancy, vertebral-basilar&#xD;
             insufficiency, bone infections, fracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kanchan Ku Sarker, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lovely Professional University,Phagwara, Kapurthala, Punjab, India.</affiliation>
  </overall_official>
  <link>
    <url>http://www.ijpbs.net/abstract.php?article=5240</url>
    <description>Kanchan Sarker, U K Mohanty, Jasobanta Sethi, &lt;em&gt;&lt;a href=&quot;http://citeweb.info/20160278206&quot;&gt;EFFECT OF SPINAL MANIPULATION ON POSTURAL INSTABILITY IN PATIENTS WITH NON SPECIFIC LOW BACK PAIN&lt;/a&gt;&lt;/em&gt; (2016)</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lovely Professional University</investigator_affiliation>
    <investigator_full_name>Kanchan Sarker</investigator_full_name>
    <investigator_title>PhD Research Scholar</investigator_title>
  </responsible_party>
  <keyword>Spinal Manipulation</keyword>
  <keyword>Postural Instability</keyword>
  <keyword>Quality of Life</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.ijpbs.net/abstract.php?article=5240</doc_url>
    </study_doc>
  </study_docs>
  <pending_results>
    <submitted>January 21, 2017</submitted>
    <returned>March 9, 2017</returned>
  </pending_results>
  <!-- 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/NCT03016676
org study id: LPU-11304873
nct id: NCT03016676
lead sponsor: 
has dmc: Yes
This study will give a new insight to the physiotherapy fraternity in the effects of spinal
      manipulation in as clinical practice, as well as the patient's community in quick
      re-establishment of functional ability, pain decrease, and improvement of quality of life for
      economic reasons. In this high opinion, application of short-term intensive spinal
      manipulation for non specific chronic low back pain treatment is desirable.
The protocol for group A included High velocity low amplitude thrust (HVLA) to the lumbar
      region of the spine between L1 and L5 vertebrae.The HVLA thrust will be performed with the
      patient side lying in a neutral.52 They take part in 12 treatment visits, 10 to 20 minutes
      sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle
      stretching, and ischemic compression of tender points) may be used as needed to facilitate
      the manual therapy.

      The protocol for group B included sets of exercise therapy. There are three components to the
      exercise therapy (ET) program: self education, supervised exercise visits, and home exercise.
      The overall objectives are to help patient's manage their LBP and prevent future LBP
      recurrences. Total number of visits 12 (e.g., ability to perform exercises independently).

      Outcome:

      Patient self-report outcomes will be collected at first baseline visit and its base on the
      pain intensity and quality of life will be assessed by using numerical pain rating scale and
      EuroQol questionnaire. Objective outcome measures will be collected at the first baseline
      visit and its base on postural instability and pressure pain threshold will be assessed by
      using Win track platform and digital algometer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.
time frame: Baseline before treatment and after 2 week of treatment
description: Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study,Change from baseline in postural instability will be measured by Win Track Platform at 2 weeks.
measure: Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.
time frame: Baseline before treatment and after 2 week of treatment
description: Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in quality of life on EuroQoL questionnaire at 2 weeks.EuroQol questionnaire is a wide accepted questionnaire for health-related quality of life and consists of two components. Its first component (EQ-5D-5L) consists of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
measure: Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.
time frame: Baseline before treatment and after 2 week of treatment
description: Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain instability on Numerical pain rating scale (NPRS). An11-point numeric pain rating scale will be used to assess pain intensity (primary outcome measure), with 0 representing "no pain" and 10 representing the "worst possible pain" at the time of the assessment. Pain intensity will be measured before and after treatment.
measure: Patients with CNSLBP will be received SM and ET to measure Pain sensitivity(Pressure pain threshold-PPT) to assess after 12 session over 2 weeks.
time frame: Baseline before treatment and treatment after 2 week of treatment
description: Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain sensitivity (PPT) on Digital algometer.Pain sensitivity (PPT) will be measured on the lumbar area bilaterally. Digital Algometer (Jagson scientific Industries, Ambala-133001, Haryana, India) will be used with a circular rounded aluminium tip, 1 cm2, and with an application rate of 25 KN/s. The measurements will be performed twice and the average of the two registrations will be filed.
arm group label: Spinal manipulation
arm group type: Experimental
description: Spinal manipulation -High velocity low amplitude thrust (HVLA), Dosages : 2 repetition at the same time, Duration-10-20 minutes. total 2 weeks.
arm group label: Exercise therapy
arm group type: Experimental
description: Exercise Therapy(ET): Exercise therapy (ET) 3 program: self education, supervised exercise visits, and home exercise. Duration-45 minutes,Total number of visits 12 for 2 weeks.
intervention type: Other
intervention name: Spinal Manipulation
description: High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae. The exact level thrust will be at the discretion of the treating practitioner determined by the level with the greatest perceivable motion restriction. The HVLA thrust will be performed with the patient side lying in a neutral.They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.
arm group label: Spinal manipulation
intervention type: Other
intervention name: Exercise therapy
description: Self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's mange their LBP and prevent future LBP recurrences. Total number of visits 12.Each visit starts with 10 minutes of self-care education to help patients establish and monitor goals aligned with the exercise program and enhance their understanding of LBP. Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).
arm group label: Exercise therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Kanchan Ku Sarker, Ph.D
role: Principal Investigator
affiliation: Lovely Professional University,Phagwara, Kapurthala, Punjab, India.
url: http://www.ijpbs.net/abstract.php?article=5240
description: Kanchan Sarker, U K Mohanty, Jasobanta Sethi, <em><a href="http://citeweb.info/20160278206">EFFECT OF SPINAL MANIPULATION ON POSTURAL INSTABILITY IN PATIENTS WITH NON SPECIFIC LOW BACK PAIN</a></em> (2016)
responsible party type: Principal Investigator
investigator affiliation: Lovely Professional University
investigator full name: Kanchan Sarker
investigator title: PhD Research Scholar
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
study doc: 
submitted: January 21, 2017
returned: March 9, 2017