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/NCT05976854</url>
    </required_header>
    <id_info>
      <org_study_id>UNIVERSITY CARDENAL HERRERA-65</org_study_id>
      <nct_id>NCT05976854</nct_id>
    </id_info>
    <brief_title>Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain</brief_title>
    <official_title>Effects of an Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cardenal Herrera University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cardenal Herrera University</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>
        60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general&#xD;
        population, patient education is the first line of treatment. For pregnant women with LBP,&#xD;
        the guidelines are the same as for the general population. In fact, prenatal education&#xD;
        programs specifically collect recommendations and educational strategies for managing this&#xD;
        pain. Within educational strategies, education in the neuroscience of pain has gained special&#xD;
        relevance in recent years due to its positive results in reducing pain in patients with low&#xD;
        back pain. Despite the beneficial effects shown in patients with low back pain, its use has&#xD;
        not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial&#xD;
        origin makes it difficult to establish an appropriate treatment for pain control. In the&#xD;
        general population, patient education is the first line of treatment. For pregnant women with&#xD;
        LBP, the guidelines are the same as for the general population. In fact, prenatal education&#xD;
        programs specifically collect recommendations and educational strategies for managing this&#xD;
        pain. Within educational strategies, education in the neuroscience of pain has gained special&#xD;
        relevance in recent years due to its positive results in reducing pain in patients with low&#xD;
        back pain. This type of education is based on reconceptualizing pain through teaching the&#xD;
        neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects&#xD;
        shown in patients with low back pain, its use has not yet been explored, to our knowledge, in&#xD;
        pregnant women with pregnancy-related low back and pelvic pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 10, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>4 weeks</time_frame>
      <description>The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disability</measure>
      <time_frame>4 weeks</time_frame>
      <description>The Roland Morris questionnaire will be used. This is a validated questionnaire for the Spanish population and has previously been used in women with lumbopelvic pain. The questionnaire assesses the degree of physical disability in patients with non-specific low back pain and is made up of 24 items that describe daily activities that may be difficult to perform due to low back pain. A point is added to each item marked &quot;yes&quot;, and a maximum score of 24 points can be obtained. The greater the number of positive responses, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kinesiophobia</measure>
      <time_frame>4 weeks</time_frame>
      <description>The short version of the Tampa TSK-11 kinesiophobia scale will be used The Spanish version of this scale has been validated in patients with acute and chronic low back pain. The scale consists of 11 items, in which each item receives a score from 1 to 4 on the Likert scale (1=strongly disagree; 4=strongly agree). The score ranges from 11 to 44 points, with higher scores indicating a greater fear of movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain catastrophizing</measure>
      <time_frame>4 weeks</time_frame>
      <description>The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appreciation of body functionality</measure>
      <time_frame>4 weeks</time_frame>
      <description>It will be measured using the Functionality Appreciation Scale (FAS). This questionnaire consists of 7 items scored on a Likert-type scale of 1 (very disagree) to 5 (strongly agree). Higher scores reflect a greater appreciation of functionality. Appreciation of body functionality is one of the dimensions of the concept of positive body image that focuses not on appearance, but on in the perception of the body's capabilities and its unconditional acceptance.There is preliminary evidence indicating that the appreciation of body functionality may be a relevant component in the context of low back pain, with patients with worse results on this scale showing worse evolution of their pain with respect to controls.To the best of our knowledge, this dimension has not been assessed in any study of low back pain in pregnant women.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Vigilance</measure>
      <time_frame>4 weeks</time_frame>
      <description>It will be measured using the Body Vigilance subscale of the Objectified Body Consciousness Scale questionnaire. This subscale is based on the premise that women are the object of constant attention by virtue of the appearance of their bodies (objectification), and that this leads them to permanent self-monitoring of their bodies to ensure that they conform to the canons of dominant beauty. The negative effects that the experience of self-objectification can produce in women are known, affecting not only their psychological state, but also consequently their physical state. A 2011 study of pregnant women found that increased body surveillance was associated with depressive symptoms and consequently unhealthy prenatal behaviors. However, the implications that could exist between this relationship and the appearance and maintenance of non-specific low back pain in pregnant women have not been studied to date.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety and depression</measure>
      <time_frame>4 weeks</time_frame>
      <description>The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of physical activity</measure>
      <time_frame>4 weeks</time_frame>
      <description>The abbreviated version of the international physical activity questionnaire (International Physical Activity Questionnaire - IPAQ - short) will be used. This is a self-administered questionnaire consisting of 7 items and collecting information on physical activity performed in the last 7 days. This questionnaire has been previously validated in 12 countries and shows adequate psychometric properties. The short version (IPAD-SF) has shown acceptable validity in the Spanish adult population.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Pain neuroscience education (PNE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler &amp; Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prenatal education (PE)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pain neuroscience education</intervention_name>
      <description>The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler &amp; Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.</description>
      <arm_group_label>Pain neuroscience education (PNE)</arm_group_label>
      <arm_group_label>Prenatal education (PE)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pregnant women older than 18 years, who are in the early third trimester of pregnancy;&#xD;
  &#xD;
            -  minimum score of 3/10 on the numerical pain scale over the past week.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  multiple pregnancy;&#xD;
  &#xD;
            -  previous spinal surgery;&#xD;
  &#xD;
            -  presence of psychiatric disorders;&#xD;
  &#xD;
            -  women who have participated in similar programs or interventions before enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>JF Lisón</name>
        <address>
          <city>Alfara del Patriarca</city>
          <state>Valencia</state>
          <zip>46113</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>JF Lisón, Dr</last_name>
        <phone>0034606503108</phone>
        <email>juanfran@uchceu.es</email>
      </contact>
      <contact_backup>
        <last_name>Vicent Benavent, Dr</last_name>
        <phone>961369000</phone>
        <phone_ext>64349</phone_ext>
        <email>vicent.benavent@uchceu.es</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
      <investigator_full_name>Juan F. Lisón Párraga, Dr</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05976854
  org study id: UNIVERSITY CARDENAL HERRERA-65
  nct id: NCT05976854
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general
        population, patient education is the first line of treatment. For pregnant women with LBP,
        the guidelines are the same as for the general population. In fact, prenatal education
        programs specifically collect recommendations and educational strategies for managing this
        pain. Within educational strategies, education in the neuroscience of pain has gained special
        relevance in recent years due to its positive results in reducing pain in patients with low
        back pain. Despite the beneficial effects shown in patients with low back pain, its use has
        not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.
  60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial
        origin makes it difficult to establish an appropriate treatment for pain control. In the
        general population, patient education is the first line of treatment. For pregnant women with
        LBP, the guidelines are the same as for the general population. In fact, prenatal education
        programs specifically collect recommendations and educational strategies for managing this
        pain. Within educational strategies, education in the neuroscience of pain has gained special
        relevance in recent years due to its positive results in reducing pain in patients with low
        back pain. This type of education is based on reconceptualizing pain through teaching the
        neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects
        shown in patients with low back pain, its use has not yet been explored, to our knowledge, in
        pregnant women with pregnancy-related low back and pelvic pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Pain intensity
  time frame: 4 weeks
  description: The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).
  measure: Disability
  time frame: 4 weeks
  description: The Roland Morris questionnaire will be used. This is a validated questionnaire for the Spanish population and has previously been used in women with lumbopelvic pain. The questionnaire assesses the degree of physical disability in patients with non-specific low back pain and is made up of 24 items that describe daily activities that may be difficult to perform due to low back pain. A point is added to each item marked "yes", and a maximum score of 24 points can be obtained. The greater the number of positive responses, the greater the disability.
  measure: Kinesiophobia
  time frame: 4 weeks
  description: The short version of the Tampa TSK-11 kinesiophobia scale will be used The Spanish version of this scale has been validated in patients with acute and chronic low back pain. The scale consists of 11 items, in which each item receives a score from 1 to 4 on the Likert scale (1=strongly disagree; 4=strongly agree). The score ranges from 11 to 44 points, with higher scores indicating a greater fear of movement.
  measure: Pain catastrophizing
  time frame: 4 weeks
  description: The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.
  measure: Appreciation of body functionality
  time frame: 4 weeks
  description: It will be measured using the Functionality Appreciation Scale (FAS). This questionnaire consists of 7 items scored on a Likert-type scale of 1 (very disagree) to 5 (strongly agree). Higher scores reflect a greater appreciation of functionality. Appreciation of body functionality is one of the dimensions of the concept of positive body image that focuses not on appearance, but on in the perception of the body's capabilities and its unconditional acceptance.There is preliminary evidence indicating that the appreciation of body functionality may be a relevant component in the context of low back pain, with patients with worse results on this scale showing worse evolution of their pain with respect to controls.To the best of our knowledge, this dimension has not been assessed in any study of low back pain in pregnant women.
  measure: Body Vigilance
  time frame: 4 weeks
  description: It will be measured using the Body Vigilance subscale of the Objectified Body Consciousness Scale questionnaire. This subscale is based on the premise that women are the object of constant attention by virtue of the appearance of their bodies (objectification), and that this leads them to permanent self-monitoring of their bodies to ensure that they conform to the canons of dominant beauty. The negative effects that the experience of self-objectification can produce in women are known, affecting not only their psychological state, but also consequently their physical state. A 2011 study of pregnant women found that increased body surveillance was associated with depressive symptoms and consequently unhealthy prenatal behaviors. However, the implications that could exist between this relationship and the appearance and maintenance of non-specific low back pain in pregnant women have not been studied to date.
  measure: Anxiety and depression
  time frame: 4 weeks
  description: The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.
  measure: Level of physical activity
  time frame: 4 weeks
  description: The abbreviated version of the international physical activity questionnaire (International Physical Activity Questionnaire - IPAQ - short) will be used. This is a self-administered questionnaire consisting of 7 items and collecting information on physical activity performed in the last 7 days. This questionnaire has been previously validated in 12 countries and shows adequate psychometric properties. The short version (IPAD-SF) has shown acceptable validity in the Spanish adult population.
  arm group label: Pain neuroscience education (PNE)
  arm group type: Experimental
  description: The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
  arm group label: Prenatal education (PE)
  arm group type: Other
  description: Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
  intervention type: Other
  intervention name: Pain neuroscience education
  description: The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
  arm group label: Pain neuroscience education (PNE)
  arm group label: Prenatal education (PE)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Cardenal Herrera University
  investigator full name: Juan F. Lisón Párraga, Dr
  investigator title: Professor
  mesh term: Low Back Pain
  sharing ipd: Undecided