<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/NCT02231554</url>
  </required_header>
  <id_info>
    <org_study_id>3297/2014</org_study_id>
    <nct_id>NCT02231554</nct_id>
  </id_info>
  <brief_title>Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial</brief_title>
  <official_title>Effectiveness of Feldenkrais Method Versus a Back School Program in Patients With Chronic Low Back Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study study is to determine whether the Feldenkrais method is effective&#xD;
      on pain control, functional recovery and quality of life in patients with chronic low back&#xD;
      pain by comparing it with a Back School program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Visual analogue scale (VAS) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>It is based on a ten point scale, where 0 means no pain and 10 the greatest pain ever. It enables the patients to express their pain intensity as numerical values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of McGill Pain Questionnaire from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Waddell Disability Index from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score &gt; 5 indicates significant disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Feldenkrais</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Feldenkrais method is a self education method that uses the somatic sensory-motor learning to enhance the functions of people in daily life activities through the awareness of their motor habits and the experience of more efficient alternatives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Back School</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Back School teaches the patient, with theoretical and practical knowledge, how to defend his own back from the pain and how to prevent their disease, considering awareness and education as important parts of the therapeutic process .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feldenkrais Method</intervention_name>
    <description>The program of Awareness Through Movement ® chosen for this study, teaches the basic movements of the column. The aim is to stimulate changes in the chronic pathological patterns and in the distorted kinesthetic perceptions that so often hinder the rehabilitation of chronic non-specific low back pain. The patients will be treated in outpatient with the Feldenkrais method. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.</description>
    <arm_group_label>Feldenkrais</arm_group_label>
    <other_name>Awarness through movement program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Back School</intervention_name>
    <description>The rehabilitation program of Back School is divided into two parts: one theoretical and one practical. To obtain an effective action not only in reducing pain but also in preventing relapse, the Back School acts on the typical risk factors of chronic non-specific low back pain, such as incorrect postures and movements, psychological stress, poor physical fitness, overweight, obesity, smoking, and insufficient knowledge of the spine. The patients will be treated in outpatient with a Back School program. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.</description>
    <arm_group_label>Back School</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic nonspecific low back pain for at least three months;&#xD;
&#xD;
          -  Subjects aged between 18 and 80 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of acute low back pain;&#xD;
&#xD;
          -  Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated&#xD;
             discs, lumbar canal stenosis);&#xD;
&#xD;
          -  CNS and/or PNS disorders;&#xD;
&#xD;
          -  Systemic inflammatory disease (eg rheumatoid arthritis);&#xD;
&#xD;
          -  Systemic infectious disease;&#xD;
&#xD;
          -  Neoplastic disease;&#xD;
&#xD;
          -  Previous Surgery;&#xD;
&#xD;
          -  Cognitive impairment;&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincenzo Maria Saraceni</last_name>
    <role>Study Director</role>
    <affiliation>Umberto I Hospital, Sapienza University of Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umberto I Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>April 30, 2015</last_update_submitted>
  <last_update_submitted_qc>April 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Teresa Paolucci</investigator_full_name>
    <investigator_title>medical director</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>quality of life</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>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/NCT02231554
org study id: 3297/2014
nct id: NCT02231554
lead sponsor: 
has dmc: Yes
The purpose of this study study is to determine whether the Feldenkrais method is effective
      on pain control, functional recovery and quality of life in patients with chronic low back
      pain by comparing it with a Back School program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change of Visual analogue scale (VAS) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: It is based on a ten point scale, where 0 means no pain and 10 the greatest pain ever. It enables the patients to express their pain intensity as numerical values.
measure: Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM).
measure: Change of McGill Pain Questionnaire from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation).
measure: Change of Waddell Disability Index from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score > 5 indicates significant disability.
measure: Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness.
arm group label: Feldenkrais
arm group type: Experimental
description: The Feldenkrais method is a self education method that uses the somatic sensory-motor learning to enhance the functions of people in daily life activities through the awareness of their motor habits and the experience of more efficient alternatives.
arm group label: Back School
arm group type: Active Comparator
description: The Back School teaches the patient, with theoretical and practical knowledge, how to defend his own back from the pain and how to prevent their disease, considering awareness and education as important parts of the therapeutic process .
intervention type: Other
intervention name: Feldenkrais Method
description: The program of Awareness Through Movement ® chosen for this study, teaches the basic movements of the column. The aim is to stimulate changes in the chronic pathological patterns and in the distorted kinesthetic perceptions that so often hinder the rehabilitation of chronic non-specific low back pain. The patients will be treated in outpatient with the Feldenkrais method. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.
arm group label: Feldenkrais
other name: Awarness through movement program
intervention type: Other
intervention name: Back School
description: The rehabilitation program of Back School is divided into two parts: one theoretical and one practical. To obtain an effective action not only in reducing pain but also in preventing relapse, the Back School acts on the typical risk factors of chronic non-specific low back pain, such as incorrect postures and movements, psychological stress, poor physical fitness, overweight, obesity, smoking, and insufficient knowledge of the spine. The patients will be treated in outpatient with a Back School program. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.
arm group label: Back School
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vincenzo Maria Saraceni
role: Study Director
affiliation: Umberto I Hospital, Sapienza University of Rome
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Teresa Paolucci
investigator title: medical director
mesh term: Back Pain
mesh term: Low Back Pain