<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/NCT02221609</url>
  </required_header>
  <id_info>
    <org_study_id>17660913.0.0000.5137</org_study_id>
    <nct_id>NCT02221609</nct_id>
  </id_info>
  <brief_title>Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial</brief_title>
  <official_title>Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontifícia Universidade Católica de Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the efficacy of a treatment based on Movement&#xD;
      System Impairment based classification (MSI) model in patients with chronic non-specific low&#xD;
      back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be recruited from orthopedic outpatient clinics as well from the community.&#xD;
      The examiner will screen the eligibility of each subject based on the eligibility criteria.&#xD;
      All eligible subjects will receive information about the study and will sign an informed&#xD;
      consent form before participating in the study.&#xD;
&#xD;
      The examiner will collect the baseline data prior to randomisation. This examiner will be&#xD;
      blinded to patients' allocation to treatment groups. The subjects will be randomly allocated&#xD;
      to one of two groups (treatment based on MSI model or general exercise) using a&#xD;
      computer-generated randomisation schedule conducted by a study researcher who will not be&#xD;
      involved with the patients and assessment of outcomes. Participant allocation will be kept in&#xD;
      a sealed opaque envelopes using a random numerical sequence. The examiner, responsible for&#xD;
      the treatment will open the envelope in front of the patient and will communicate him about&#xD;
      which treatment group he will be part of. The clinical outcomes of this study will be&#xD;
      assessed before, after the treatment (2 months) and at 4 and 6 months after randomisation.&#xD;
&#xD;
      Descriptive analyses will be done to check for data normality. The between-group comparisons&#xD;
      to obtain the mean effects of the treatments will be conducted by means of interaction terms&#xD;
      (group versus time interactions) using Linear Mixed Models. All data will be given to a&#xD;
      statistician who will perform the statistical analysis in coded form. The statistical&#xD;
      analysis will be done according to the principles of intention to treat. The SPSS 19 and&#xD;
      SigmaPlot 10 will be used for these analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>2 months after randomisation</time_frame>
    <description>Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>2 months after randomisation</time_frame>
    <description>Disability will be measured by the 24-item Roland Morris Disability Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>4 and 6 months after randomisation</time_frame>
    <description>Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>4 and 6 months after randomisation</time_frame>
    <description>Disability will be measured by the 24-item Roland Morris Disability Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global perceived effect</measure>
    <time_frame>2, 4 and 6 months after randomisation</time_frame>
    <description>Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Treatment based on Movement System Impairment based model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment based on Movement System Impairment based classification model is composed by patient education, analysis and modification of daily living activities and prescription of specific exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The general exercise program consists of stretching exercises of the trunk and lower limbs muscles and strengthening exercises of the trunk muscles (Hayden et al., 2005; Rainville et al., 2004).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment based on Movement System Impairment model</intervention_name>
    <description>The analysis and modification of daily activities will be performed by identifying and analyzing the patients activities that provoke their symptoms. The patient will be taught on how to correct his posture and limit the movements that increase the amount of stress on the lumbar spine. The prescription of specific exercises is done based on the patient's classification into one of 5 categories of the MSI model. These exercises consist of practicing the movement tests performed at the initial assessment in a corrected form, emphasizing the control of the lumbar spine movement and increasing movement on the adjacent joints. Patients will also advised to repeat the exercises at home at least once a day. 12 treatment sessions are planned for each patient (2 sessions per week during the first 4 weeks and 1 session per week during the last 4 weeks). Each treatment session has an estimated duration of 45-60 minutes. Patients will register their home exercise in an exercise diary.</description>
    <arm_group_label>Treatment based on Movement System Impairment based model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General exercise</intervention_name>
    <description>The general exercise program consists of 12 treatment sessions with estimated duration between 45-60 minutes per session (2 sessions per week for the first 4 weeks and 1 session per week in last 4 weeks). Each session is also done individually by a trained physical therapist. The patients perform an exercise program that starts with a 5-minutes warm-up followed by stretching exercises. Those stretching exercises address the six directions of lumbar motion and the lower limbs muscles. The patient also performs strengthening exercises of the trunk muscles. Based on correct performance of the exercises, the subject may progress through increased load as tolerated. He is also advised to perform these exercises at home and receive figures of the exercises with written instructions. The exercise program will be adapted according to American College of Sports Medicine recommendations (Garber et al., 2011). Patients will register their home exercise in an exercise diary.</description>
    <arm_group_label>General exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of both genders between 18 and 65 years of age with chronic non-specific LBP&#xD;
             (pain for more than 3 months) with a pain intensity of at least 3 points measured by a&#xD;
             0-10 points pain numerical rating scale&#xD;
&#xD;
          -  Subjects must be able to stand and walk independently&#xD;
&#xD;
          -  Subjects must be able to read in Portuguese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any contraindication to physical exercise according to the guidelines of&#xD;
             the American College of Sports Medicine&#xD;
&#xD;
          -  Subjects with severe depression (measured by depression, anxiety and stress scale -&#xD;
             DASS)&#xD;
&#xD;
          -  Subjects with serious spinal pathologies (fractures, tumors, and inflammatory&#xD;
             pathologies such as ankylosing spondylitis), nerve root compromise (disc herniation&#xD;
             and spondylolisthesis with neurological compromise, spinal stenosis, and others),&#xD;
             serious cardiorespiratory diseases, previous back surgery or pregnancy.&#xD;
&#xD;
          -  Subjects that cannot be classified into any of the five categories of the Movement&#xD;
             System Impairment model upon initial assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonardo Costa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Cidade de Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontificia Universidade Catolica de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30535-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.</citation>
    <PMID>21694556</PMID>
  </reference>
  <reference>
    <citation>Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.</citation>
    <PMID>16034851</PMID>
  </reference>
  <reference>
    <citation>Rainville J, Hartigan C, Martinez E, Limke J, Jouve C, Finno M. Exercise as a treatment for chronic low back pain. Spine J. 2004 Jan-Feb;4(1):106-15. doi: 10.1016/s1529-9430(03)00174-8.</citation>
    <PMID>14749199</PMID>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 23, 2016</last_update_submitted>
  <last_update_submitted_qc>August 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Cidade de Sao Paulo</investigator_affiliation>
    <investigator_full_name>Daniel Camara Azevedo</investigator_full_name>
    <investigator_title>Phd candidate</investigator_title>
  </responsible_party>
  <keyword>Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago</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/NCT02221609
org study id: 17660913.0.0000.5137
nct id: NCT02221609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to investigate the efficacy of a treatment based on Movement
      System Impairment based classification (MSI) model in patients with chronic non-specific low
      back pain.
The subjects will be recruited from orthopedic outpatient clinics as well from the community.
      The examiner will screen the eligibility of each subject based on the eligibility criteria.
      All eligible subjects will receive information about the study and will sign an informed
      consent form before participating in the study.

      The examiner will collect the baseline data prior to randomisation. This examiner will be
      blinded to patients' allocation to treatment groups. The subjects will be randomly allocated
      to one of two groups (treatment based on MSI model or general exercise) using a
      computer-generated randomisation schedule conducted by a study researcher who will not be
      involved with the patients and assessment of outcomes. Participant allocation will be kept in
      a sealed opaque envelopes using a random numerical sequence. The examiner, responsible for
      the treatment will open the envelope in front of the patient and will communicate him about
      which treatment group he will be part of. The clinical outcomes of this study will be
      assessed before, after the treatment (2 months) and at 4 and 6 months after randomisation.

      Descriptive analyses will be done to check for data normality. The between-group comparisons
      to obtain the mean effects of the treatments will be conducted by means of interaction terms
      (group versus time interactions) using Linear Mixed Models. All data will be given to a
      statistician who will perform the statistical analysis in coded form. The statistical
      analysis will be done according to the principles of intention to treat. The SPSS 19 and
      SigmaPlot 10 will be used for these analyses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain Intensity
time frame: 2 months after randomisation
description: Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
measure: Disability
time frame: 2 months after randomisation
description: Disability will be measured by the 24-item Roland Morris Disability Questionnaire
measure: Pain Intensity
time frame: 4 and 6 months after randomisation
description: Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
measure: Disability
time frame: 4 and 6 months after randomisation
description: Disability will be measured by the 24-item Roland Morris Disability Questionnaire
measure: Global perceived effect
time frame: 2, 4 and 6 months after randomisation
description: Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
arm group label: Treatment based on Movement System Impairment based model
arm group type: Experimental
description: Treatment based on Movement System Impairment based classification model is composed by patient education, analysis and modification of daily living activities and prescription of specific exercises
arm group label: General exercise
arm group type: Active Comparator
description: The general exercise program consists of stretching exercises of the trunk and lower limbs muscles and strengthening exercises of the trunk muscles (Hayden et al., 2005; Rainville et al., 2004).
intervention type: Other
intervention name: Treatment based on Movement System Impairment model
description: The analysis and modification of daily activities will be performed by identifying and analyzing the patients activities that provoke their symptoms. The patient will be taught on how to correct his posture and limit the movements that increase the amount of stress on the lumbar spine. The prescription of specific exercises is done based on the patient's classification into one of 5 categories of the MSI model. These exercises consist of practicing the movement tests performed at the initial assessment in a corrected form, emphasizing the control of the lumbar spine movement and increasing movement on the adjacent joints. Patients will also advised to repeat the exercises at home at least once a day. 12 treatment sessions are planned for each patient (2 sessions per week during the first 4 weeks and 1 session per week during the last 4 weeks). Each treatment session has an estimated duration of 45-60 minutes. Patients will register their home exercise in an exercise diary.
arm group label: Treatment based on Movement System Impairment based model
intervention type: Other
intervention name: General exercise
description: The general exercise program consists of 12 treatment sessions with estimated duration between 45-60 minutes per session (2 sessions per week for the first 4 weeks and 1 session per week in last 4 weeks). Each session is also done individually by a trained physical therapist. The patients perform an exercise program that starts with a 5-minutes warm-up followed by stretching exercises. Those stretching exercises address the six directions of lumbar motion and the lower limbs muscles. The patient also performs strengthening exercises of the trunk muscles. Based on correct performance of the exercises, the subject may progress through increased load as tolerated. He is also advised to perform these exercises at home and receive figures of the exercises with written instructions. The exercise program will be adapted according to American College of Sports Medicine recommendations (Garber et al., 2011). Patients will register their home exercise in an exercise diary.
arm group label: General exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Leonardo Costa, PhD
role: Principal Investigator
affiliation: Universidade Cidade de Sao Paulo
facility: 
country: Brazil
citation: Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PMID: 21694556
citation: Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
PMID: 16034851
citation: Rainville J, Hartigan C, Martinez E, Limke J, Jouve C, Finno M. Exercise as a treatment for chronic low back pain. Spine J. 2004 Jan-Feb;4(1):106-15. doi: 10.1016/s1529-9430(03)00174-8.
PMID: 14749199
responsible party type: Principal Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Daniel Camara Azevedo
investigator title: Phd candidate
mesh term: Back Pain
mesh term: Low Back Pain