xml: <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/NCT05996991</url>
    </required_header>
    <id_info>
      <org_study_id>62827822.2.0000.5504</org_study_id>
      <nct_id>NCT05996991</nct_id>
    </id_info>
    <brief_title>The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects</brief_title>
    <official_title>Understanding the Impact of Positive, Neutral and Negative Expectation Speech Regarding Manual Therapy Intervention in Patients With Chronic Low Back Pain: a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade Federal de Sao Carlos</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade Federal de Sao Carlos</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 objective of this study will be to identify the short-term impact of positive, neutral,&#xD;
        or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will&#xD;
        be the global perceived effect of improvement, patient's expectations regarding spinal&#xD;
        manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic&#xD;
        encounter in patients with chronic low back pain (CLBP). This study will enroll 60&#xD;
        participants with CLBP aged between 18 and 60 years.&#xD;
  &#xD;
        This is an exploratory randomized clinical trial. The three groups will receive a manual&#xD;
        therapy session after watching the video proposed for their group.&#xD;
  &#xD;
        First participants will be assessed for pain intensity, low back pain disability,&#xD;
        psychosocial aspects, and expectations related to treatment. Secondly, a researcher not&#xD;
        involved in the recruitment of patients will randomly allocate the participants into three&#xD;
        different groups (G1- group submitted to positive expectation, G2- group submitted to neutral&#xD;
        expectation, and G3- group submitted to negative expectation). After the allocation, the&#xD;
        participants will watch a short video (no more than 3 minutes) delivering positive, negative,&#xD;
        or neutral messages regarding SMT. And finally, a physiotherapist will administer one session&#xD;
        of SMT and participants will be re-assessed to investigate the immediate effect of the videos&#xD;
        on the pain intensity, global perceived effect of improvement, and expectations.&#xD;
  &#xD;
        Ultimately, patients will be submitted to a semi-structured interview in which their&#xD;
        perceptions about the videos will be investigated.&#xD;
  &#xD;
        Outcomes will be assessed just immediately after one SMT session.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The term &quot;contextual effect&quot; has been used to reinforce the view that the placebo&#xD;
        effect should be understood as an effect related to the therapeutic context, and not&#xD;
        restricted to the use of inert treatments. Thus, the placebo effect is inherent to any&#xD;
        therapeutic context and also can be used to enhance the effects of treatment with active&#xD;
        components. There is evidence of the effectiveness of manipulative therapy in the treatment&#xD;
        of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect&#xD;
        is small. Thus, strategies to enhance the effects of this therapy, such as through the use of&#xD;
        context factors, may contribute to better therapeutic outcomes. The literature describes that&#xD;
        positively induced expectations can trigger a placebo effect. There are previous studies that&#xD;
        investigated the effect of different speech on SMT in patients with chronic neck pain, but&#xD;
        there is no study in CLBP. In addition, no previous study investigated further the&#xD;
        perceptions of patients regarding the content and perceptions of the videos.&#xD;
  &#xD;
        The objective of this study will be to identify the short-term impact of positive, neutral,&#xD;
        or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will&#xD;
        be the global perceived effect of improvement, patient's expectations regarding spinal&#xD;
        manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic&#xD;
        encounter in patients with chronic low back pain (CLBP)&#xD;
  &#xD;
        Methods: it will be a randomized controlled trial with a blinded assessor. It will be&#xD;
        investigated the effect of the use of a hidden conditioning procedure and the induction of&#xD;
        positive expectations on pain intensity after the administration of a manipulative therapy&#xD;
        approach.&#xD;
  &#xD;
        This is an exploratory randomized clinical trial. The three groups will receive one session&#xD;
        of SMT after watching the video proposed for their group.&#xD;
  &#xD;
        First participants will be assessed for pain intensity, low back pain disability,&#xD;
        psychosocial aspects, and expectations related to treatment. Secondly, a researcher not&#xD;
        involved in the recruitment of patients will randomly allocate the participants into three&#xD;
        different groups (G1- group submitted to positive expectation, G2- group submitted to neutral&#xD;
        expectation, and G3- group submitted to negative expectation). After the allocation, the&#xD;
        participants will watch a short video (no more than 3 minutes) delivering positive, negative,&#xD;
        or neutral messages regarding SMT. And finally, a physiotherapist will administer one session&#xD;
        of SMT and participants will be re-assessed to investigate the immediate effect of the videos&#xD;
        on the pain intensity, global perceived effect of improvement, and expectations. Ultimately,&#xD;
        patients will be submitted to a semi-structured interview in which their perceptions about&#xD;
        the videos will be investigated. It will help to understand if the content of the videos&#xD;
        actually causes an impact on the expectations of the patients.&#xD;
  &#xD;
        The main hypothesis of this study is that the group submitted to the positive expectation&#xD;
        speech will have a higher hypoalgesic effect, greater perception of improvement, and higher&#xD;
        expectations regarding SMT than the other groups immediately post-treatment.&#xD;
  &#xD;
        Outcomes will be assessed just immediately after one SMT session.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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 Clinical Trial with three parallel arms</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>one-hour after the baseline assessment</time_frame>
      <description>The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity in this trial and consists in a sequence of numbers from zero to ten, in which zero represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Global Perceived Effect (GPE) of Improvement</measure>
      <time_frame>one-hour after the baseline assessment</time_frame>
      <description>The GPE of improvement used for this trial is an 11-point scale that ranges from &quot;-5&quot; (&quot;vastly worse&quot;) through zero (&quot;no change&quot;) to &quot;+5&quot; (&quot;completely recovered&quot;) and patients are asked: &quot;Compared to when this episode first started, how would you describe your orofacial pain these days?&quot;. A higher score indicates higher perception of recovery from the condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low-back Pain (LBP) Expectation Scale</measure>
      <time_frame>one-hour after the baseline assessment</time_frame>
      <description>The LBP Expectation Scale assesses the patient's previous expectation that the LBP will improve. The participant is asked to respond using an 11-point scale, ranging from zero to ten, where zero represents &quot;no chance&quot; and ten represents &quot;very likely&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Expectations in Chronic Pain Scale (TEC)</measure>
      <time_frame>one-hour after the baseline assessment</time_frame>
      <description>The TEC scale is a self-report questionnaire measuring patients' ideal and predicted expectations. The scale has 9 items which were designed to measure two aspects of expectations, namely process and outcome expectations. Instructions are as follows: 'The following questions are about your expectations of the treatment you will receive for your chronic pain. For each question, please check the box that best corresponds to (1) what you ideally hope will happen (in an ideal world, what would you want to happen) during your health care appointment(s) and (2) what you realistically expect will happen (in real life, what do you expect will actually happen) during your health care appointment(s). For each item, patients are asked to select the extent to which they agree with the statement on a 5-point scale (1 = strongly disagree to 5 = strongly agree) in terms of their ideal and predicted expectations. Each item is thus scored twice by participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Empathy - Care Scale</measure>
      <time_frame>one-hour after the baseline assessment</time_frame>
      <description>The Consultation and Relational Empathy (CARE) Measure is a person-centred process measure that was developed and researched at the Departments of General Practice in Glasgow University and Edinburgh University. The CARE Measure is a quick (only 10 questions), clear and easy to complete patient-completed questionnaire. It measures empathy in the context of the therapeutic relationship during a one-on-one consultation between a clinician and a patient. The score of the CARE ranges from 10 to 50. Higher the score, higher the perceived quality of the encounter with healthcare professionals.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>G1 - Positive Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants of G1 will watch a short video (no more than 3 minutes) delivering a positive message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>G2 - Neutral Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants of G1 will watch a short video (no more than 3 minutes) delivering a neutral message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>G2 - Negative Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants of G1 will watch a short video (no more than 3 minutes) delivering a negative message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Positive expectation speech regarding spinal manipulative therapy</intervention_name>
      <description>Patients will watch a short video with positive expectations regarding spinal manipulative therapy.</description>
      <arm_group_label>G1 - Positive Expectation Group + Spinal Manipulative Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Neutral expectation speech regarding spinal manipulative therapy</intervention_name>
      <description>Patients will watch a short video with neutral expectations regarding spinal manipulative therapy.</description>
      <arm_group_label>G2 - Neutral Expectation Group + Spinal Manipulative Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Negative expectation speech regarding spinal manipulative therapy</intervention_name>
      <description>Patients will watch a short video with negative expectations regarding spinal manipulative therapy.</description>
      <arm_group_label>G2 - Negative Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <other_name>Manual Therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Spinal Manipulative Therapy</intervention_name>
      <description>One session of Spinal Manipulative Therapy. The researcher will administer a posterior and inferior push on the opposite anterior superior iliac spine (ASIS) while passively rotating the subject on the side to be manipulated. The spinal manipulations will be repeated four times during a 5-minute period, with impulses oscillating between the right and left ASIS. In addition, we will administrate mobilizations (anterior-posterior central mobilization), applied for 1 minute in each lumbar vertebra (from L5 to L1), using grade I joint mobilization (patients positioned in the ventral decubitus position).</description>
      <arm_group_label>G1 - Positive Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <arm_group_label>G2 - Negative Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <arm_group_label>G2 - Neutral Expectation Group + Spinal Manipulative Therapy</arm_group_label>
      <other_name>Manual Therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who report non-specific CLBP (in which the specific nociceptive source cannot&#xD;
               be identified, confirmed by a medical assessment) for at least three months duration;&#xD;
  &#xD;
            2. Age ranged from 18 years to 60 years&#xD;
  &#xD;
            3. Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the&#xD;
               measurement error &gt; 2 reported for the NPRS);&#xD;
  &#xD;
            4. Patients able to speak and understand Portuguese well to fill out the questionnaires.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous poor experiences with SMT through the application of a brief screening&#xD;
               questionnaire&#xD;
  &#xD;
            2. Pregnancy&#xD;
  &#xD;
            3. Specific low back pain disorders like radiculopathy or lumbar stenosis or chronic&#xD;
               degenerative disorders, i.e., uncontrolled cardiovascular, metabolic, or systemic&#xD;
               diseases, neurological or psychiatric diseases, and stroke sequelae&#xD;
  &#xD;
            4. Undergoing other therapeutic interventions for chronic pain and low back pain&#xD;
               (including surgeries) in the last 3 months&#xD;
  &#xD;
            5. Presence of contraindications to SMT&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Thais C Chaves, PHD</last_name>
      <role>Study Chair</role>
      <affiliation>Federal University of São Carlos - UFSCar</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thais C Chaves, PhD</last_name>
      <phone>05516 996092206</phone>
      <email>thaischaves@ufscar.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thamiris C Lima, PhD</last_name>
      <phone>05516991533628</phone>
      <email>thamiriscl@estudante.ufscar.br</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Federal University of São Carlos - Department of Physical Therapy</name>
        <address>
          <city>São Carlos</city>
          <state>São Paulo</state>
          <zip>13.565-905</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <contact>
        <last_name>Thais C Chaves, PhD</last_name>
        <phone>05516996092206</phone>
        <email>thaischaves@ufscar.br</email>
      </contact>
      <contact_backup>
        <last_name>Thamiris C Lima, PhD</last_name>
        <phone>05516991533628</phone>
        <email>thamiriscl@estudante.ufscar.br</email>
      </contact_backup>
      <investigator>
        <last_name>Bianca E Saes Campanha, Graduation</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
      <investigator_full_name>Thais Chaves</investigator_full_name>
      <investigator_title>Adjunct Professor</investigator_title>
    </responsible_party>
    <keyword>Placebo Effect</keyword>
    <keyword>Chronic low-back Pain</keyword>
    <keyword>Spinal Manipulative Therapy</keyword>
    <keyword>Expectations</keyword>
    <keyword>contextual effect</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>
  
  
text: 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/NCT05996991
  org study id: 62827822.2.0000.5504
  nct id: NCT05996991
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study will be to identify the short-term impact of positive, neutral,
        or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will
        be the global perceived effect of improvement, patient's expectations regarding spinal
        manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic
        encounter in patients with chronic low back pain (CLBP). This study will enroll 60
        participants with CLBP aged between 18 and 60 years.
  
        This is an exploratory randomized clinical trial. The three groups will receive a manual
        therapy session after watching the video proposed for their group.
  
        First participants will be assessed for pain intensity, low back pain disability,
        psychosocial aspects, and expectations related to treatment. Secondly, a researcher not
        involved in the recruitment of patients will randomly allocate the participants into three
        different groups (G1- group submitted to positive expectation, G2- group submitted to neutral
        expectation, and G3- group submitted to negative expectation). After the allocation, the
        participants will watch a short video (no more than 3 minutes) delivering positive, negative,
        or neutral messages regarding SMT. And finally, a physiotherapist will administer one session
        of SMT and participants will be re-assessed to investigate the immediate effect of the videos
        on the pain intensity, global perceived effect of improvement, and expectations.
  
        Ultimately, patients will be submitted to a semi-structured interview in which their
        perceptions about the videos will be investigated.
  
        Outcomes will be assessed just immediately after one SMT session.
  Background: The term "contextual effect" has been used to reinforce the view that the placebo
        effect should be understood as an effect related to the therapeutic context, and not
        restricted to the use of inert treatments. Thus, the placebo effect is inherent to any
        therapeutic context and also can be used to enhance the effects of treatment with active
        components. There is evidence of the effectiveness of manipulative therapy in the treatment
        of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect
        is small. Thus, strategies to enhance the effects of this therapy, such as through the use of
        context factors, may contribute to better therapeutic outcomes. The literature describes that
        positively induced expectations can trigger a placebo effect. There are previous studies that
        investigated the effect of different speech on SMT in patients with chronic neck pain, but
        there is no study in CLBP. In addition, no previous study investigated further the
        perceptions of patients regarding the content and perceptions of the videos.
  
        The objective of this study will be to identify the short-term impact of positive, neutral,
        or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will
        be the global perceived effect of improvement, patient's expectations regarding spinal
        manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic
        encounter in patients with chronic low back pain (CLBP)
  
        Methods: it will be a randomized controlled trial with a blinded assessor. It will be
        investigated the effect of the use of a hidden conditioning procedure and the induction of
        positive expectations on pain intensity after the administration of a manipulative therapy
        approach.
  
        This is an exploratory randomized clinical trial. The three groups will receive one session
        of SMT after watching the video proposed for their group.
  
        First participants will be assessed for pain intensity, low back pain disability,
        psychosocial aspects, and expectations related to treatment. Secondly, a researcher not
        involved in the recruitment of patients will randomly allocate the participants into three
        different groups (G1- group submitted to positive expectation, G2- group submitted to neutral
        expectation, and G3- group submitted to negative expectation). After the allocation, the
        participants will watch a short video (no more than 3 minutes) delivering positive, negative,
        or neutral messages regarding SMT. And finally, a physiotherapist will administer one session
        of SMT and participants will be re-assessed to investigate the immediate effect of the videos
        on the pain intensity, global perceived effect of improvement, and expectations. Ultimately,
        patients will be submitted to a semi-structured interview in which their perceptions about
        the videos will be investigated. It will help to understand if the content of the videos
        actually causes an impact on the expectations of the patients.
  
        The main hypothesis of this study is that the group submitted to the positive expectation
        speech will have a higher hypoalgesic effect, greater perception of improvement, and higher
        expectations regarding SMT than the other groups immediately post-treatment.
  
        Outcomes will be assessed just immediately after one SMT session.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Clinical Trial with three parallel arms
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Pain intensity
  time frame: one-hour after the baseline assessment
  description: The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity in this trial and consists in a sequence of numbers from zero to ten, in which zero represents "no pain" and 10 represents "worst pain imaginable"
  measure: Global Perceived Effect (GPE) of Improvement
  time frame: one-hour after the baseline assessment
  description: The GPE of improvement used for this trial is an 11-point scale that ranges from "-5" ("vastly worse") through zero ("no change") to "+5" ("completely recovered") and patients are asked: "Compared to when this episode first started, how would you describe your orofacial pain these days?". A higher score indicates higher perception of recovery from the condition.
  measure: Low-back Pain (LBP) Expectation Scale
  time frame: one-hour after the baseline assessment
  description: The LBP Expectation Scale assesses the patient's previous expectation that the LBP will improve. The participant is asked to respond using an 11-point scale, ranging from zero to ten, where zero represents "no chance" and ten represents "very likely".
  measure: Treatment Expectations in Chronic Pain Scale (TEC)
  time frame: one-hour after the baseline assessment
  description: The TEC scale is a self-report questionnaire measuring patients' ideal and predicted expectations. The scale has 9 items which were designed to measure two aspects of expectations, namely process and outcome expectations. Instructions are as follows: 'The following questions are about your expectations of the treatment you will receive for your chronic pain. For each question, please check the box that best corresponds to (1) what you ideally hope will happen (in an ideal world, what would you want to happen) during your health care appointment(s) and (2) what you realistically expect will happen (in real life, what do you expect will actually happen) during your health care appointment(s). For each item, patients are asked to select the extent to which they agree with the statement on a 5-point scale (1 = strongly disagree to 5 = strongly agree) in terms of their ideal and predicted expectations. Each item is thus scored twice by participants.
  measure: Empathy - Care Scale
  time frame: one-hour after the baseline assessment
  description: The Consultation and Relational Empathy (CARE) Measure is a person-centred process measure that was developed and researched at the Departments of General Practice in Glasgow University and Edinburgh University. The CARE Measure is a quick (only 10 questions), clear and easy to complete patient-completed questionnaire. It measures empathy in the context of the therapeutic relationship during a one-on-one consultation between a clinician and a patient. The score of the CARE ranges from 10 to 50. Higher the score, higher the perceived quality of the encounter with healthcare professionals.
  arm group label: G1 - Positive Expectation Group + Spinal Manipulative Therapy
  arm group type: Experimental
  description: The participants of G1 will watch a short video (no more than 3 minutes) delivering a positive message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.
  arm group label: G2 - Neutral Expectation Group + Spinal Manipulative Therapy
  arm group type: Active Comparator
  description: The participants of G1 will watch a short video (no more than 3 minutes) delivering a neutral message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.
  arm group label: G2 - Negative Expectation Group + Spinal Manipulative Therapy
  arm group type: Active Comparator
  description: The participants of G1 will watch a short video (no more than 3 minutes) delivering a negative message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.
  intervention type: Other
  intervention name: Positive expectation speech regarding spinal manipulative therapy
  description: Patients will watch a short video with positive expectations regarding spinal manipulative therapy.
  arm group label: G1 - Positive Expectation Group + Spinal Manipulative Therapy
  intervention type: Other
  intervention name: Neutral expectation speech regarding spinal manipulative therapy
  description: Patients will watch a short video with neutral expectations regarding spinal manipulative therapy.
  arm group label: G2 - Neutral Expectation Group + Spinal Manipulative Therapy
  intervention type: Other
  intervention name: Negative expectation speech regarding spinal manipulative therapy
  description: Patients will watch a short video with negative expectations regarding spinal manipulative therapy.
  arm group label: G2 - Negative Expectation Group + Spinal Manipulative Therapy
  other name: Manual Therapy
  intervention type: Procedure
  intervention name: Spinal Manipulative Therapy
  description: One session of Spinal Manipulative Therapy. The researcher will administer a posterior and inferior push on the opposite anterior superior iliac spine (ASIS) while passively rotating the subject on the side to be manipulated. The spinal manipulations will be repeated four times during a 5-minute period, with impulses oscillating between the right and left ASIS. In addition, we will administrate mobilizations (anterior-posterior central mobilization), applied for 1 minute in each lumbar vertebra (from L5 to L1), using grade I joint mobilization (patients positioned in the ventral decubitus position).
  arm group label: G1 - Positive Expectation Group + Spinal Manipulative Therapy
  arm group label: G2 - Negative Expectation Group + Spinal Manipulative Therapy
  arm group label: G2 - Neutral Expectation Group + Spinal Manipulative Therapy
  other name: Manual Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Thais C Chaves, PHD
  role: Study Chair
  affiliation: Federal University of São Carlos - UFSCar
  last name: Thais C Chaves, PhD
  phone: 05516 996092206
  email: thaischaves@ufscar.br
  last name: Thamiris C Lima, PhD
  phone: 05516991533628
  email: thamiriscl@estudante.ufscar.br
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Universidade Federal de Sao Carlos
  investigator full name: Thais Chaves
  investigator title: Adjunct Professor
  mesh term: Back Pain
  mesh term: Low Back Pain