<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/NCT01719276</url>
  </required_header>
  <id_info>
    <org_study_id>mauriciomag20</org_study_id>
    <nct_id>NCT01719276</nct_id>
  </id_info>
  <brief_title>Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain</brief_title>
  <official_title>EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of graded activity program and&#xD;
      supervised exercise on pain, functional disability, quality of life, global perceived effect,&#xD;
      return to work, physical activity, physical capacity and strength of the lower limbs in&#xD;
      patients with chronic non-specific low back pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To contrast the efficacy of of graded activity program and supervised exercise on&#xD;
      pain, functional disability, quality of life, global perceived effect, return to work,&#xD;
      physical activity, physical capacity and strength of the lower limbs in patients with chronic&#xD;
      non-specific low back pain&#xD;
&#xD;
      Design: Sixty-six will be randomized into two groups namely: Graded Activity program (GA)(n =&#xD;
      33) and supervised exercise (SE) (n = 33). The primary clinical outcomes will be pain,&#xD;
      assessed with the numerical pain scale and McGill Pain Questionnaire, and disability assessed&#xD;
      with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with Global&#xD;
      Perceived Effect, quality of life, return to work, physical activity, functional capacity and&#xD;
      strength of the lower limbs. The program lasts for 6 weeks, and sessions happen twice a week,&#xD;
      with duration of one hour each. Evaluations will be performed before(baseline), after&#xD;
      (6weeks) and with a follow-up 3 and 6 months after treatment. Data will be collected by a&#xD;
      blinded examiner who also had made the allocation of patients to groups. Significance level&#xD;
      is established at 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</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</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Disability</measure>
    <time_frame>6 weeks</time_frame>
    <description>Roland Morris Disability Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 weeks</time_frame>
    <description>Short-Form Health Survey Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect</measure>
    <time_frame>6 weeks</time_frame>
    <description>Global Perceived Effect Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients will be asked if returned their professional activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habitual physical activity</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Baecke questionnaire on habitual physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Capacity</measure>
    <time_frame>6 weeks</time_frame>
    <description>physical capacity tests (sit-to-stand and 50-foot walk)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>Tampa Scale of Kinesophobia (TSK)</time_frame>
    <description>self-applied questionnaire consisting of 17 items, which was developed to measure the fear of movement due to cLBP. Each question has 4 response options (strongly disagree, disagree, agree, and strongly agree) with scores respectively ranging from 1 to 4 points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Graded Activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise treadmill, Strengthening of the lower limbs and trunk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stretching, Strengthening, Motor Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Graded Activity</intervention_name>
    <description>The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.</description>
    <arm_group_label>Graded Activity</arm_group_label>
    <arm_group_label>Supervised exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised Exercises</intervention_name>
    <description>The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.</description>
    <arm_group_label>Graded Activity</arm_group_label>
    <arm_group_label>Supervised exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-specific chronic low back pain for at least three months, age&#xD;
             between 18 and 65 year of both genders and with a minimum pain intensity score of&#xD;
             three in the 11-point Pain Numerical Rating Scale (ranging from 0 to 10 points).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected serious spinal pathology (fractures, tumors, inflammatory or&#xD;
             infective diseases of the spine);&#xD;
&#xD;
               -  Nerve root compromise;&#xD;
&#xD;
               -  Comorbid health conditions that would prevent active participation in the&#xD;
                  exercise programs;&#xD;
&#xD;
               -  Pregnancy;&#xD;
&#xD;
               -  Cardio Respiratory illnesses;&#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>Amelia P Marques, PHD</last_name>
    <role>Study Director</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mauricio O Magalhaes, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medicine School of the University Of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>June 13, 2014</last_update_submitted>
  <last_update_submitted_qc>June 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Mauricio Oliveira Magalhães</investigator_full_name>
    <investigator_title>Mauricio Oliveira Magalhães</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>
  <!-- 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/NCT01719276
org study id: mauriciomag20
nct id: NCT01719276
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the efficacy of graded activity program and
      supervised exercise on pain, functional disability, quality of life, global perceived effect,
      return to work, physical activity, physical capacity and strength of the lower limbs in
      patients with chronic non-specific low back pain
Objective: To contrast the efficacy of of graded activity program and supervised exercise on
      pain, functional disability, quality of life, global perceived effect, return to work,
      physical activity, physical capacity and strength of the lower limbs in patients with chronic
      non-specific low back pain

      Design: Sixty-six will be randomized into two groups namely: Graded Activity program (GA)(n =
      33) and supervised exercise (SE) (n = 33). The primary clinical outcomes will be pain,
      assessed with the numerical pain scale and McGill Pain Questionnaire, and disability assessed
      with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with Global
      Perceived Effect, quality of life, return to work, physical activity, functional capacity and
      strength of the lower limbs. The program lasts for 6 weeks, and sessions happen twice a week,
      with duration of one hour each. Evaluations will be performed before(baseline), after
      (6weeks) and with a follow-up 3 and 6 months after treatment. Data will be collected by a
      blinded examiner who also had made the allocation of patients to groups. Significance level
      is established at 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain
time frame: 6 weeks
description: Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
measure: Functional Disability
time frame: 6 weeks
description: Roland Morris Disability Questionnaire
measure: Quality of life
time frame: 6 weeks
description: Short-Form Health Survey Questionnaire
measure: Global Perceived Effect
time frame: 6 weeks
description: Global Perceived Effect Scale
measure: Return to work
time frame: 6 weeks
description: Patients will be asked if returned their professional activities.
measure: Habitual physical activity
time frame: 6 weeks
description: The Baecke questionnaire on habitual physical activity
measure: Physical Capacity
time frame: 6 weeks
description: physical capacity tests (sit-to-stand and 50-foot walk)
measure: Kinesiophobia
time frame: Tampa Scale of Kinesophobia (TSK)
description: self-applied questionnaire consisting of 17 items, which was developed to measure the fear of movement due to cLBP. Each question has 4 response options (strongly disagree, disagree, agree, and strongly agree) with scores respectively ranging from 1 to 4 points.
arm group label: Graded Activity
arm group type: Active Comparator
description: Exercise treadmill, Strengthening of the lower limbs and trunk
arm group label: Supervised exercises
arm group type: Active Comparator
description: Stretching, Strengthening, Motor Control
intervention type: Other
intervention name: Graded Activity
description: The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
arm group label: Graded Activity
arm group label: Supervised exercises
intervention type: Other
intervention name: Supervised Exercises
description: The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.
arm group label: Graded Activity
arm group label: Supervised exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amelia P Marques, PHD
role: Study Director
affiliation: University of São Paulo
last name: Mauricio O Magalhaes, MSc
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Mauricio Oliveira Magalhães
investigator title: Mauricio Oliveira Magalhães
mesh term: Back Pain
mesh term: Low Back Pain