<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/NCT02241538</url>
  </required_header>
  <id_info>
    <org_study_id>29303014.7.0000.0064</org_study_id>
    <nct_id>NCT02241538</nct_id>
  </id_info>
  <brief_title>Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain</brief_title>
  <official_title>Cost Effectiveness and Effectiveness of the Addition of Different Weekly Frequency of Modified Pilates Method Exercises to a Minimal Intervention in the Treatment of Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is a major cause of disability and absenteeism and the supervised exercise is a&#xD;
      recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates&#xD;
      method has shown to be effective in improving pain and disability in patients with chronic&#xD;
      low back pain (CLBP). However, there is still no evidence about the ideal number of sessions&#xD;
      for the treatment and the interval between sessions to achieve better efficacy of this method&#xD;
      for these patients. Thus, the aim of this study is to investigate the effectiveness of the&#xD;
      Pilates method with different weekly frequency of sessions in the treatment of patients with&#xD;
      nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific&#xD;
      CLBP lasting more than three months and aged between 18 and 80 years. Participants will be&#xD;
      randomly divided into four groups (n = 74 patients per group): Control Group will receive an&#xD;
      educational booklet and no additional exercise, Pilates 1 Group will receive a program of&#xD;
      exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the&#xD;
      same program of exercises twice a week for six weeks and Pilates 3 Group will receive the&#xD;
      same program of exercises three times a week for six weeks. The outcomes overall disability&#xD;
      (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional&#xD;
      scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating&#xD;
      scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a&#xD;
      blinded assessor before, six weeks, six and 12 months after randomization. Investigators&#xD;
      expect that the largest number of weekly sessions of Pilates method may influence the results&#xD;
      in all analyzes (short, medium and long term), since there is a relationship between&#xD;
      frequency of exercises and effect size of the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Six weeks after randomization</time_frame>
    <description>Pain intensity will be measured by an 11-point Pain Numerical Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>Six weeks after randomization</time_frame>
    <description>Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Six and twelve months after randomization</time_frame>
    <description>Pain intensity will be measured by an 11-point Pain Numerical Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>Six and twelve months after randomization</time_frame>
    <description>Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global impression of recovery</measure>
    <time_frame>Six weeks, six and twelve months after randomization</time_frame>
    <description>Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific disability</measure>
    <time_frame>Six weeks, six and twelve months after randomizaion</time_frame>
    <description>Specific disability will be evaluated by an 11-point Patient-specific Functional Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>Six weeks, six and twelve months after randomization</time_frame>
    <description>Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-Related Catastrophizing</measure>
    <time_frame>Six weeks, six and twelve months after randomization</time_frame>
    <description>Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Effectiveness</measure>
    <time_frame>Six weeks, six and twelve months after randomization</time_frame>
    <description>Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality Adjusted Life Years</measure>
    <time_frame>Six weeks, six and twelve months after randomization</time_frame>
    <description>Quality adjusted life years will be measured by the SF-6D questionnaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">296</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Pilates 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilates 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilates 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group will not receive additional exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pilates 1</intervention_name>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
    <arm_group_label>Pilates 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pilates 2</intervention_name>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
    <arm_group_label>Pilates 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pilates 3</intervention_name>
    <description>Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).</description>
    <arm_group_label>Pilates 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group did not receive additional exercise.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic nonspecific low back pain longer 12 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra indications to physical exercise&#xD;
&#xD;
          -  Serious spinal pathologies (e. g. tumors, fractures and inflammatory diseases)&#xD;
&#xD;
          -  Nerve root compromise&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous surgery on spine&#xD;
&#xD;
          -  Pilates treatment for low back pain in the last three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Physical Therapy Outpatient Department</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>03071000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</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>Cristina Maria Nunes Cabral</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pilates-based exercises</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/NCT02241538
org study id: 29303014.7.0000.0064
nct id: NCT02241538
lead sponsor: 
has dmc: Yes
Low back pain is a major cause of disability and absenteeism and the supervised exercise is a
      recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates
      method has shown to be effective in improving pain and disability in patients with chronic
      low back pain (CLBP). However, there is still no evidence about the ideal number of sessions
      for the treatment and the interval between sessions to achieve better efficacy of this method
      for these patients. Thus, the aim of this study is to investigate the effectiveness of the
      Pilates method with different weekly frequency of sessions in the treatment of patients with
      nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific
      CLBP lasting more than three months and aged between 18 and 80 years. Participants will be
      randomly divided into four groups (n = 74 patients per group): Control Group will receive an
      educational booklet and no additional exercise, Pilates 1 Group will receive a program of
      exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the
      same program of exercises twice a week for six weeks and Pilates 3 Group will receive the
      same program of exercises three times a week for six weeks. The outcomes overall disability
      (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional
      scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating
      scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a
      blinded assessor before, six weeks, six and 12 months after randomization. Investigators
      expect that the largest number of weekly sessions of Pilates method may influence the results
      in all analyzes (short, medium and long term), since there is a relationship between
      frequency of exercises and effect size of the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain intensity
time frame: Six weeks after randomization
description: Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
measure: Disability
time frame: Six weeks after randomization
description: Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
measure: Pain intensity
time frame: Six and twelve months after randomization
description: Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
measure: Disability
time frame: Six and twelve months after randomization
description: Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
measure: Global impression of recovery
time frame: Six weeks, six and twelve months after randomization
description: Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
measure: Specific disability
time frame: Six weeks, six and twelve months after randomizaion
description: Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
measure: Kinesiophobia
time frame: Six weeks, six and twelve months after randomization
description: Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
measure: Pain-Related Catastrophizing
time frame: Six weeks, six and twelve months after randomization
description: Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale
measure: Cost Effectiveness
time frame: Six weeks, six and twelve months after randomization
description: Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
measure: Quality Adjusted Life Years
time frame: Six weeks, six and twelve months after randomization
description: Quality adjusted life years will be measured by the SF-6D questionnaire
arm group label: Pilates 1
arm group type: Experimental
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Pilates 2
arm group type: Experimental
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Pilates 3
arm group type: Experimental
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Control
arm group type: Active Comparator
description: Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group will not receive additional exercise.
intervention type: Device
intervention name: Pilates 1
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Pilates 1
intervention type: Device
intervention name: Pilates 2
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Pilates 2
intervention type: Device
intervention name: Pilates 3
description: Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
arm group label: Pilates 3
intervention type: Device
intervention name: Control
description: Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group did not receive additional exercise.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Cristina Maria Nunes Cabral
investigator title: Associate Professor
mesh term: Back Pain
mesh term: Low Back Pain