<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/NCT03273114</url>
  </required_header>
  <id_info>
    <org_study_id>neymeziat</org_study_id>
    <nct_id>NCT03273114</nct_id>
  </id_info>
  <brief_title>Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain</brief_title>
  <official_title>Cognitive Functional Therapy (CFT) Compared With a Combined Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Universitário Augusto Motta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Universitário Augusto Motta</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>
      There is evidence, of a single randomized controlled trial, that CFT is better than combined&#xD;
      manual therapy and motor control exercise for chronic low back pain. However, this study had&#xD;
      significant methodological shortcomings regarding the failure to carry out the intention to&#xD;
      treat analysis and a considerable loss of follow-up of patients. As it is, it is important to&#xD;
      carry out more studies involving CFT compared to other interventions already used in clinical&#xD;
      practice and to correct these methodological shortcomings. Therefore, the aim of the study is&#xD;
      to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific&#xD;
      low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trial with concealed allocation, blinded assessor, blinded participants&#xD;
      and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12&#xD;
      months after randomization, to assess the maintenance of any effect of treatment. The&#xD;
      patients in the CFT group will be treated by a physical therapists that attended twice the&#xD;
      CFT workshops with two of the tutors of the method. She completed 106 hours of training&#xD;
      including workshops, patient examinations and a pilot study with the supervision of a&#xD;
      physical therapist with more than three years of clinical experience in CFT. Patients in&#xD;
      CORE-MT group will be treated by a physical therapist with clinical experience in manual&#xD;
      therapy and core training exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">June 28, 2020</completion_date>
  <primary_completion_date type="Actual">June 28, 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 trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 8 weeks, 6 and 12 months after randomization. Both arms include active treatments, and participants will not know whether they are in the experimental group or control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>8 weeks</time_frame>
    <description>It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is &quot;no pain&quot; and 10 is &quot;the worst pain imaginable.&quot; Participants will be asked to answer about their pain levels based on the last seven days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability associated to low back pain</measure>
    <time_frame>8 weeks</time_frame>
    <description>It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global impression of recovery</measure>
    <time_frame>8 weeks, 6 and 12 months after randomization</time_frame>
    <description>It will be evaluated based on the Global Perceived Effect Scale (GPES) which is an 11-point scale ranging from -5 ('vastly worse'), through 0 (no change) to +5 (completely recovered).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>6 and 12 months after randomization</time_frame>
    <description>It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is &quot;no pain&quot; and 10 is &quot;the worst pain imaginable.&quot; Participants will be asked to answer about their pain levels based on the last seven days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability associated to low back pain</measure>
    <time_frame>6 and 12 months after randomization</time_frame>
    <description>It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months after randomization</time_frame>
    <description>This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophization (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months after randomization</time_frame>
    <description>It will be evaluated by the question &quot;When I feel pain, it's terrible and I feel it's never going to get any better.&quot;with the response options ranging from &quot;Never do that&quot; = 0 to &quot;Always do that&quot; = 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months months after randomization</time_frame>
    <description>It will be evaluated by the question &quot;During the past month have you often been bothered by feeling down, depressed or hopeless?&quot; with the response options ranging from &quot;Never&quot; = 0 to &quot;All the time&quot; = 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months months after randomization</time_frame>
    <description>It will be assessed by the question &quot;Physical activity might harm my back&quot; and the response options will range from 0 (&quot;completely disagree&quot;) to 10 (&quot;completely agree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months months after randomization</time_frame>
    <description>It will be evaluated by the question &quot;Do you feel stressed? and the response options will range from 0 (&quot;completely disagree&quot;) to 10 (&quot;completely agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep (mediator of outcome)</measure>
    <time_frame>8 weeks, 6 and 12 months months after randomization</time_frame>
    <description>It will be evaluated by the question &quot;Did you have sleep problems last month?&quot; based on Subjective Health Complaints Inventory19. The response options will be &quot;Not at all&quot;=0, &quot;A little&quot;=1, &quot;Some&quot;=2, and &quot;Serious&quot;=3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Back Pain</condition>
  <condition>Pain</condition>
  <condition>Signs and Symptoms</condition>
  <condition>Neuromuscular Manifestations</condition>
  <arm_group>
    <arm_group_label>Cognitive Functional Therapy (CFT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Functional Therapy (CFT) is a behavioral intervention that addresses multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, educating them about pain mechanisms, increasing mental strength, and control of their body. This is done with functional tasks performed by individuals training them to reduce excessive muscle activity in the trunk and generate behavioral changes related to pain, from postures and provocative movements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Core Training Exercise and Manual Therapy (CORE-MT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Functional Therapy</intervention_name>
    <description>There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):&#xD;
The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.&#xD;
Specific Functional training is designed to normalize maladaptive or provocative movement and posture.&#xD;
Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)&#xD;
Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies</description>
    <arm_group_label>Cognitive Functional Therapy (CFT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core Training Exercise and Manual Therapy</intervention_name>
    <description>According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT.</description>
    <arm_group_label>Core Training Exercise and Manual Therapy (CORE-MT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 65 years&#xD;
&#xD;
          -  Low back pain for more than 3 months&#xD;
&#xD;
          -  Disability score of 14% or more on the Oswestry Disability Index (ODI)&#xD;
&#xD;
          -  Being able to walk independently with or without support&#xD;
&#xD;
          -  Understand Portuguese well enough to be able to fill in the questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Main pain area is not the lumbar spine (from T12 to buttocks)&#xD;
&#xD;
          -  Main pain as leg pain (eg: nerve root compression or herniated disc with radicular&#xD;
             pain / radiculopathy, lateral and central stenosis)&#xD;
&#xD;
          -  Less than 6 months after lumbar spine, lower limb or abdomen surgery&#xD;
&#xD;
          -  Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3&#xD;
             months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing&#xD;
             spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto da Coluna</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13084-759</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Meziat Filho N. Changing beliefs for changing movement and pain: Classification-based cognitive functional therapy (CB-CFT) for chronic non-specific low back pain. Man Ther. 2016 Feb;21:303-6. doi: 10.1016/j.math.2015.04.013. Epub 2015 Apr 16.</citation>
    <PMID>25920336</PMID>
  </reference>
  <reference>
    <citation>Meziat Filho N, Mendonca R, Nogueira LA. Lack of confidence in the lower limb: Cognitive Functional Therapy (CFT) for a unilateral loading impairment in chronic non-specific low back pain. Case report. Man Ther. 2016 Sep;25:104-8. doi: 10.1016/j.math.2016.02.007. Epub 2016 Mar 12.</citation>
    <PMID>27052627</PMID>
  </reference>
  <reference>
    <citation>Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4.</citation>
    <PMID>23208945</PMID>
  </reference>
  <reference>
    <citation>O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, Dankaerts W, Tighe A, Allworthy L, Dolan L, Bargary N, O'Sullivan K. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156.</citation>
    <PMID>26033941</PMID>
  </reference>
  <reference>
    <citation>Caneiro JP, Smith A, Rabey M, Moseley GL, O'Sullivan P. Process of Change in Pain-Related Fear: Clinical Insights From a Single Case Report of Persistent Back Pain Managed With Cognitive Functional Therapy. J Orthop Sports Phys Ther. 2017 Sep;47(9):637-651. doi: 10.2519/jospt.2017.7371. Epub 2017 Jul 13.</citation>
    <PMID>28704623</PMID>
  </reference>
  <reference>
    <citation>Bunzli S, McEvoy S, Dankaerts W, O'Sullivan P, O'Sullivan K. Patient Perspectives on Participation in Cognitive Functional Therapy for Chronic Low Back Pain. Phys Ther. 2016 Sep;96(9):1397-407. doi: 10.2522/ptj.20140570. Epub 2016 Mar 24.</citation>
    <PMID>27013577</PMID>
  </reference>
  <reference>
    <citation>Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.</citation>
    <PMID>27745712</PMID>
  </reference>
  <reference>
    <citation>O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available.</citation>
    <PMID>21821612</PMID>
  </reference>
  <reference>
    <citation>Goyal M, Haythornthwaite JA. Is It Time to Make Mind-Body Approaches Available for Chronic Low Back Pain? JAMA. 2016 Mar 22-29;315(12):1236-7. doi: 10.1001/jama.2016.2437. No abstract available.</citation>
    <PMID>27002443</PMID>
  </reference>
  <reference>
    <citation>Menke JM. Do manual therapies help low back pain? A comparative effectiveness meta-analysis. Spine (Phila Pa 1976). 2014 Apr 1;39(7):E463-72. doi: 10.1097/BRS.0000000000000230.</citation>
    <PMID>24480940</PMID>
  </reference>
  <reference>
    <citation>Kent P, Mirkhil S, Keating J, Buchbinder R, Manniche C, Albert HB. The concurrent validity of brief screening questions for anxiety, depression, social isolation, catastrophization, and fear of movement in people with low back pain. Clin J Pain. 2014 Jun;30(6):479-89. doi: 10.1097/AJP.0000000000000010.</citation>
    <PMID>24281277</PMID>
  </reference>
  <reference>
    <citation>Paungmali A, Joseph LH, Sitilertpisan P, Pirunsan U, Uthaikhup S. Lumbopelvic Core Stabilization Exercise and Pain Modulation Among Individuals with Chronic Nonspecific Low Back Pain. Pain Pract. 2017 Nov;17(8):1008-1014. doi: 10.1111/papr.12552. Epub 2017 Feb 25.</citation>
    <PMID>28042685</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>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Universitário Augusto Motta</investigator_affiliation>
    <investigator_full_name>Ney Armando Meziat Filho</investigator_full_name>
    <investigator_title>Assistant Professor, Rehabilitation Sciences</investigator_title>
  </responsible_party>
  <keyword>back pain</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>exercise therapy</keyword>
  <keyword>cognitive functional therapy</keyword>
  <keyword>low back pain</keyword>
  <keyword>backache</keyword>
  <keyword>lower back pain</keyword>
  <keyword>lumbago</keyword>
  <keyword>multidimensional</keyword>
  <keyword>biopsychosocial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromuscular Manifestations</mesh_term>
    <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/NCT03273114
org study id: neymeziat
nct id: NCT03273114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is evidence, of a single randomized controlled trial, that CFT is better than combined
      manual therapy and motor control exercise for chronic low back pain. However, this study had
      significant methodological shortcomings regarding the failure to carry out the intention to
      treat analysis and a considerable loss of follow-up of patients. As it is, it is important to
      carry out more studies involving CFT compared to other interventions already used in clinical
      practice and to correct these methodological shortcomings. Therefore, the aim of the study is
      to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific
      low back pain.
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants
      and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12
      months after randomization, to assess the maintenance of any effect of treatment. The
      patients in the CFT group will be treated by a physical therapists that attended twice the
      CFT workshops with two of the tutors of the method. She completed 106 hours of training
      including workshops, patient examinations and a pilot study with the supervision of a
      physical therapist with more than three years of clinical experience in CFT. Patients in
      CORE-MT group will be treated by a physical therapist with clinical experience in manual
      therapy and core training exercises.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 8 weeks, 6 and 12 months after randomization. Both arms include active treatments, and participants will not know whether they are in the experimental group or control group.
measure: Pain intensity
time frame: 8 weeks
description: It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days
measure: Disability associated to low back pain
time frame: 8 weeks
description: It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
measure: Global impression of recovery
time frame: 8 weeks, 6 and 12 months after randomization
description: It will be evaluated based on the Global Perceived Effect Scale (GPES) which is an 11-point scale ranging from -5 ('vastly worse'), through 0 (no change) to +5 (completely recovered).
measure: Pain intensity
time frame: 6 and 12 months after randomization
description: It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days.
measure: Disability associated to low back pain
time frame: 6 and 12 months after randomization
description: It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
measure: Patient Satisfaction (mediator of outcome)
time frame: 8 weeks, 6 and 12 months after randomization
description: This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied
measure: Catastrophization (mediator of outcome)
time frame: 8 weeks, 6 and 12 months after randomization
description: It will be evaluated by the question "When I feel pain, it's terrible and I feel it's never going to get any better."with the response options ranging from "Never do that" = 0 to "Always do that" = 10.
measure: Depression (mediator of outcome)
time frame: 8 weeks, 6 and 12 months months after randomization
description: It will be evaluated by the question "During the past month have you often been bothered by feeling down, depressed or hopeless?" with the response options ranging from "Never" = 0 to "All the time" = 10.
measure: Fear of movement (mediator of outcome)
time frame: 8 weeks, 6 and 12 months months after randomization
description: It will be assessed by the question "Physical activity might harm my back" and the response options will range from 0 ("completely disagree") to 10 ("completely agree).
measure: Stress (mediator of outcome)
time frame: 8 weeks, 6 and 12 months months after randomization
description: It will be evaluated by the question "Do you feel stressed? and the response options will range from 0 ("completely disagree") to 10 ("completely agree)
measure: Sleep (mediator of outcome)
time frame: 8 weeks, 6 and 12 months months after randomization
description: It will be evaluated by the question "Did you have sleep problems last month?" based on Subjective Health Complaints Inventory19. The response options will be "Not at all"=0, "A little"=1, "Some"=2, and "Serious"=3
arm group label: Cognitive Functional Therapy (CFT)
arm group type: Experimental
description: Cognitive Functional Therapy (CFT) is a behavioral intervention that addresses multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, educating them about pain mechanisms, increasing mental strength, and control of their body. This is done with functional tasks performed by individuals training them to reduce excessive muscle activity in the trunk and generate behavioral changes related to pain, from postures and provocative movements.
arm group label: Core Training Exercise and Manual Therapy (CORE-MT)
arm group type: Active Comparator
description: The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT).
intervention type: Behavioral
intervention name: Cognitive Functional Therapy
description: There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.
Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)
Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies
arm group label: Cognitive Functional Therapy (CFT)
intervention type: Other
intervention name: Core Training Exercise and Manual Therapy
description: According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT.
arm group label: Core Training Exercise and Manual Therapy (CORE-MT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Meziat Filho N. Changing beliefs for changing movement and pain: Classification-based cognitive functional therapy (CB-CFT) for chronic non-specific low back pain. Man Ther. 2016 Feb;21:303-6. doi: 10.1016/j.math.2015.04.013. Epub 2015 Apr 16.
PMID: 25920336
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PMID: 27052627
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PMID: 16034851
responsible party type: Principal Investigator
investigator affiliation: Centro Universitário Augusto Motta
investigator full name: Ney Armando Meziat Filho
investigator title: Assistant Professor, Rehabilitation Sciences
mesh term: Neuromuscular Manifestations
mesh term: Back Pain
mesh term: Low Back Pain