<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/NCT03778970</url>
  </required_header>
  <id_info>
    <org_study_id>69172017.1.0000.5440</org_study_id>
    <nct_id>NCT03778970</nct_id>
  </id_info>
  <brief_title>Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain</brief_title>
  <official_title>Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to compare the effects of an exercise program based on&#xD;
      movement control exercises associated with self-management advice (SME) or pain neuroscience&#xD;
      education (PNE) on the outcomes of pain intensity and pain disability in patients with&#xD;
      chronic non-specific low back pain (CLBP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: One hundred and four volunteers (104) aged 18-50 years with chronic&#xD;
      non-specific low back pain.&#xD;
&#xD;
      Interventions: The volunteers will be randomized into two treatment groups: self-management&#xD;
      education and movement control exercises or pain neuroscience education and exercises based&#xD;
      on movement control exercises. Two workshops of 40 minutes each will be administered as&#xD;
      education approach and the exercise program along 2 months ( and 12 sessions distributed over&#xD;
      2 months.&#xD;
&#xD;
      Main outcome measures: Primary outcomes will include pain intensity and low back disability,&#xD;
      and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia,&#xD;
      exercise adherence and global perceived effect. These will be measured pre- and&#xD;
      post-intervention and at the 1-month follow-up. Statistical analysis will be conducted&#xD;
      following treatment intent principles, and treatment effects will be calculated using a mixed&#xD;
      linear model, considering intervention groups as a factor and assessments over time as&#xD;
      repeated measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>
    <intervention_model_description>Randomized controlled clinical trial, superiority trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The participants will be submitted to Pain Neuroscience Education or Self-Management Education plus movement control exercises. They will not be aware of the education approach they will receive. The assessors will also not be aware whether the participant received Pain Neuroscience Education or Self-Management Education.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity - Numerical Pain Rating Scale (NPRS)</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>The NPRS used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference (MCID) of 2.4 among patients with CLBP receiving exercise or education.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low Back Pain Disability</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two. Previous research has found that ODI showed responsiveness to change for patients with CLBP, with MCID of 8 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>Validated and translated to Brazilian-Portuguese, the Pain Catastrophizing scale (Br-PCS) is a self-administered questionnaire that presents 13 questions, divided into 3 domains: helplessness, magnification, and rumination. The scale has 5 points: 0 (minimum); 1 (slight); 2 (moderate); 3 (intense); and 4 (very intense). The final score ranges from 0 to 52 points, with the psychological risk being directly proportional to higher scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Self-Efficacy</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>Validated for Brazilian-Portuguese, the Pain Self-Efficacy Scale (PSE) presents 10 questions scored from 0 (Not at all confident) to 6 (Completely confident). The score achieved on this scale can range from 0 to 60, higher values reflecting stronger self-efficacy beliefs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance Beliefs</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>Validated and translated to Brazilian-Portuguese, the Fear Avoidance Beliefs Questionnaire (FABQ-Brazil) is composed of 16 self-report items, subdivided into the FABQ-Phys, addressing beliefs related to occupational activities, and the FABQ-Work, work-related beliefs. However, the FABQ-Work score should be measured by adding items 6,7,9,10,11,12, and 15 with a score ranging from 0 to 42 and the FABQ-Phys through the sum of items 2,3,4, and 5, with the score ranging from 0 to 24 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Adherence</measure>
    <time_frame>at the beginning of following session, immediately after and at 1-month follow-up</time_frame>
    <description>We will administer the Brazilian Portuguese version of the scale cross-culturally adapted. The tool is comprised of 16 items, 6 items directly assessing behavior adherence (Section B), while 10 additional items related to non-adherence reasons (Section C). The 16 items were classified using an ordinal scale of 5 possible answers (0 = strongly agree to 4 = totally disagree) with a possible score range from 0 to 64. A higher overall adherence score indicated better adherence to exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect</measure>
    <time_frame>Immediately after and at 1-month follow-up</time_frame>
    <description>The Global Perceived Effect Scale has the purpose of investigating musculoskeletal features, where the patient has the capacity to report improvement or deterioration over time, usually used to measure the effect of a therapy with the question: &quot;Compared to when this episode began, how would you describe your low back currently?&quot; Scored from -5 (much worse) to +5 (fully recovered), higher scores indicate improvement in the condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Pain Neuroscience Education + Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PNE will follow the principles established by Explain Pain, addressing reconceptualization of pain, emphasizing modern neuroscience concepts. The PNE workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Management Education + Exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Self-Management Education (SME) strategy will be aligned with the &quot;Back Book&quot; concepts, focused on behavior change and encouraging participants to be active despite of the pain. The SME workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain Neuroscience Education</intervention_name>
    <description>Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop</description>
    <arm_group_label>Pain Neuroscience Education + Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-Management Education</intervention_name>
    <description>A self-management education (2 sessions during 40 minutes) administered by an interactive workshop</description>
    <arm_group_label>Self-Management Education + Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Movement Control Exercises</intervention_name>
    <description>Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.</description>
    <arm_group_label>Pain Neuroscience Education + Exercises</arm_group_label>
    <arm_group_label>Self-Management Education + Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) non-specific chronic low back pain with a mechanical constituent caused by certain&#xD;
        postures, activities, and movements, in addition to having at least 3 months of pain and/or&#xD;
        episodes for at least half the previous 6 days, located between T12 and the gluteal folds;&#xD;
        (2) pain intensity scores greater than 2 and greater than 14% on the Oswestry Low Back&#xD;
        Disability Index and (3) positive results in 2 or more of the 6 tests to determine movement&#xD;
        control impairment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) red flags such as tumors or neoplastic diseases in the spine, inflammatory diseases,&#xD;
        infections, and fractures; (2) central and peripheral, psychiatric, rheumatologic, and&#xD;
        cardiac neurological diseases; (3) acute and symptomatic radiculopathy, lumbar stenosis,&#xD;
        and spondylolisthesis; (4) pregnant women; and (5) individuals submitted to&#xD;
        physiotherapeutic treatment during the last 6 months. Finally, volunteers will be advised&#xD;
        about the non-use of pain medications 24 hours before the evaluations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thais Chaves, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Professor - Ribeirão Preto Medical School - University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tiago Del Antônio, MSc</last_name>
    <phone>+554384240199</phone>
    <email>tiagodantonio@uenp.edu.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thais Chaves, PhD</last_name>
    <phone>+551633154413</phone>
    <email>chavestc@fmrp.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Physical Therapy Clinic</name>
      <address>
        <city>Jacarezinho</city>
        <state>Paraná</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiago Del Antônio, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thais C Chaves, PhD</last_name>
      <phone>55 016 3315 4413</phone>
      <email>chavestc@fmrp.usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Tiago AG Del Antônio, MSc</last_name>
      <phone>+5543 84240199</phone>
      <email>tiagodantonio@uenp.edu.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Thais Cristina Chaves</investigator_full_name>
    <investigator_title>Professor PhD</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/NCT03778970
org study id: 69172017.1.0000.5440
nct id: NCT03778970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to compare the effects of an exercise program based on
      movement control exercises associated with self-management advice (SME) or pain neuroscience
      education (PNE) on the outcomes of pain intensity and pain disability in patients with
      chronic non-specific low back pain (CLBP).
Participants: One hundred and four volunteers (104) aged 18-50 years with chronic
      non-specific low back pain.

      Interventions: The volunteers will be randomized into two treatment groups: self-management
      education and movement control exercises or pain neuroscience education and exercises based
      on movement control exercises. Two workshops of 40 minutes each will be administered as
      education approach and the exercise program along 2 months ( and 12 sessions distributed over
      2 months.

      Main outcome measures: Primary outcomes will include pain intensity and low back disability,
      and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia,
      exercise adherence and global perceived effect. These will be measured pre- and
      post-intervention and at the 1-month follow-up. Statistical analysis will be conducted
      following treatment intent principles, and treatment effects will be calculated using a mixed
      linear model, considering intervention groups as a factor and assessments over time as
      repeated measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial, superiority trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The participants will be submitted to Pain Neuroscience Education or Self-Management Education plus movement control exercises. They will not be aware of the education approach they will receive. The assessors will also not be aware whether the participant received Pain Neuroscience Education or Self-Management Education.
measure: Pain intensity - Numerical Pain Rating Scale (NPRS)
time frame: Immediately after and at 1-month follow-up
description: The NPRS used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference (MCID) of 2.4 among patients with CLBP receiving exercise or education.
measure: Low Back Pain Disability
time frame: Immediately after and at 1-month follow-up
description: The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two. Previous research has found that ODI showed responsiveness to change for patients with CLBP, with MCID of 8 points.
measure: Pain Catastrophizing
time frame: Immediately after and at 1-month follow-up
description: Validated and translated to Brazilian-Portuguese, the Pain Catastrophizing scale (Br-PCS) is a self-administered questionnaire that presents 13 questions, divided into 3 domains: helplessness, magnification, and rumination. The scale has 5 points: 0 (minimum); 1 (slight); 2 (moderate); 3 (intense); and 4 (very intense). The final score ranges from 0 to 52 points, with the psychological risk being directly proportional to higher scores.
measure: Pain Self-Efficacy
time frame: Immediately after and at 1-month follow-up
description: Validated for Brazilian-Portuguese, the Pain Self-Efficacy Scale (PSE) presents 10 questions scored from 0 (Not at all confident) to 6 (Completely confident). The score achieved on this scale can range from 0 to 60, higher values reflecting stronger self-efficacy beliefs.
measure: Fear Avoidance Beliefs
time frame: Immediately after and at 1-month follow-up
description: Validated and translated to Brazilian-Portuguese, the Fear Avoidance Beliefs Questionnaire (FABQ-Brazil) is composed of 16 self-report items, subdivided into the FABQ-Phys, addressing beliefs related to occupational activities, and the FABQ-Work, work-related beliefs. However, the FABQ-Work score should be measured by adding items 6,7,9,10,11,12, and 15 with a score ranging from 0 to 42 and the FABQ-Phys through the sum of items 2,3,4, and 5, with the score ranging from 0 to 24 points.
measure: Exercise Adherence
time frame: at the beginning of following session, immediately after and at 1-month follow-up
description: We will administer the Brazilian Portuguese version of the scale cross-culturally adapted. The tool is comprised of 16 items, 6 items directly assessing behavior adherence (Section B), while 10 additional items related to non-adherence reasons (Section C). The 16 items were classified using an ordinal scale of 5 possible answers (0 = strongly agree to 4 = totally disagree) with a possible score range from 0 to 64. A higher overall adherence score indicated better adherence to exercise.
measure: Global Perceived Effect
time frame: Immediately after and at 1-month follow-up
description: The Global Perceived Effect Scale has the purpose of investigating musculoskeletal features, where the patient has the capacity to report improvement or deterioration over time, usually used to measure the effect of a therapy with the question: "Compared to when this episode began, how would you describe your low back currently?" Scored from -5 (much worse) to +5 (fully recovered), higher scores indicate improvement in the condition.
arm group label: Pain Neuroscience Education + Exercises
arm group type: Experimental
description: The PNE will follow the principles established by Explain Pain, addressing reconceptualization of pain, emphasizing modern neuroscience concepts. The PNE workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.
arm group label: Self-Management Education + Exercises
arm group type: Active Comparator
description: The Self-Management Education (SME) strategy will be aligned with the "Back Book" concepts, focused on behavior change and encouraging participants to be active despite of the pain. The SME workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.
intervention type: Other
intervention name: Pain Neuroscience Education
description: Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
arm group label: Pain Neuroscience Education + Exercises
intervention type: Other
intervention name: Self-Management Education
description: A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
arm group label: Self-Management Education + Exercises
intervention type: Other
intervention name: Movement Control Exercises
description: Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
arm group label: Pain Neuroscience Education + Exercises
arm group label: Self-Management Education + Exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Thais Chaves, PhD
role: Study Director
affiliation: Professor - Ribeirão Preto Medical School - University of São Paulo
last name: Tiago Del Antônio, MSc
phone: +554384240199
email: tiagodantonio@uenp.edu.br
last name: Thais Chaves, PhD
phone: +551633154413
email: chavestc@fmrp.usp.br
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Thais Cristina Chaves
investigator title: Professor PhD
mesh term: Back Pain
mesh term: Low Back Pain