<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/NCT03796481</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2018/0277/Amend</org_study_id>
    <nct_id>NCT03796481</nct_id>
  </id_info>
  <brief_title>Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia</brief_title>
  <official_title>Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is focused on people with chronic spinal pain. To investigate the impact of sleep&#xD;
      problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will&#xD;
      be compared to 45 people with chronic spinal pain without insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">July 28, 2022</completion_date>
  <primary_completion_date type="Actual">July 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory (Numeric Rating Scale): Pain intensity</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported pain: The question &quot;please rate your pain by circling the one number that best describes your pain on the AVERAGE&quot; is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory: Pain Interference</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central sensitization Inventory</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Thresholds</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Participants will be monitored in the comfort of their own home by ambulatory polysomnography. This will provide the following parameters: time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging, sleep efficiency, sleep fragmentation, respiratory parameters, cardiac and myoclonic activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburg Sleep Quality Index</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brugmann Fatigue Scale</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression rating scale</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity using Actigraphy</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Physical activity: Continuous assessment of physical activity and rest/activity cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey - 36 items Mental Health</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey - 36 items Physical Health</measure>
    <time_frame>Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.</time_frame>
    <description>Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">123</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <condition>Chronic Neck Pain</condition>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        People with chronic spinal pain with and without comorbid insomnia (cases vs controls)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria cases:&#xD;
&#xD;
          -  nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain,&#xD;
             failed back surgery syndrome &gt; 3 years prior, chronic whiplash, or chronic non&#xD;
             traumatic neck pain)&#xD;
&#xD;
          -  aged between 18 and 65 years&#xD;
&#xD;
          -  seeking care because of neck pain or low back pain&#xD;
&#xD;
          -  native dutch speaker&#xD;
&#xD;
          -  having insomnia: in the absence of other intrinsic sleep disorders and shift work,&#xD;
             insomnia is defined as &gt; 30 minutes of sleep latency and/or minutes awake after sleep&#xD;
             onset for &gt; 3 days / week for &gt; 6 months&#xD;
&#xD;
          -  living or working within a radius of 50 km around the test location&#xD;
&#xD;
          -  not starting new treatments or medication and continuing their usual care 6 weeks&#xD;
             prior to and during study participation (to obtain steady state)&#xD;
&#xD;
          -  referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the&#xD;
             assessments&#xD;
&#xD;
          -  nonspecific failed back surgery &gt; 3 years are permitted&#xD;
&#xD;
          -  not undertaking exercise (&gt;3 metabolic equivalents) 3 days before the experiment&#xD;
&#xD;
        Exclusion criteria cases:&#xD;
&#xD;
          -  severe underlying sleep pathology (identified through baseline data of&#xD;
             polysomnography)&#xD;
&#xD;
          -  neuropathic pain&#xD;
&#xD;
          -  chronic widespread pain&#xD;
&#xD;
          -  being pregnant or pregnancy (including giving birth) in the preceding year&#xD;
&#xD;
          -  history of specific spinal surgery&#xD;
&#xD;
          -  thoracic pain in absence of neck or low back pain&#xD;
&#xD;
          -  shift workers&#xD;
&#xD;
          -  present clinical depression&#xD;
&#xD;
          -  BMI ≥ 30&#xD;
&#xD;
        Inclusion criteria controls:&#xD;
&#xD;
          -  native dutch speaking&#xD;
&#xD;
          -  18 to 65 years of age&#xD;
&#xD;
          -  having chronic nonspecific chronic spinal pain (≥3 days per week and ≥3 months of&#xD;
             chronic low back pain, failed back surgery syndrome &gt; 3 years prior, chronic whiplash,&#xD;
             or chronic non traumatic neck pain)&#xD;
&#xD;
          -  referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the&#xD;
             assessments&#xD;
&#xD;
          -  not undertaking exercise (&gt;3 metabolic equivalents) 3 days before the experiment&#xD;
&#xD;
          -  No new medication 6 weeks prior to the assessment&#xD;
&#xD;
          -  currently not undergoing any treatment (excl. medication) for chronic spinal pain&#xD;
&#xD;
        Exclusion criteria controls:&#xD;
&#xD;
          -  specific medical conditions (neuropathic pain, specific neck of back surgery,&#xD;
             osteoporotic vertebral fractures, or rheumatologic diseases)&#xD;
&#xD;
          -  chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)&#xD;
&#xD;
          -  having insomnia (in the absence of other intrinsic sleep disorders and shift work,&#xD;
             insomnia is defined as &gt; 30 minutes of sleep latency and/or minutes awake after sleep&#xD;
             onset for &gt; 3 days / week for &gt; 6 months)&#xD;
&#xD;
          -  severe underlying sleep pathology&#xD;
&#xD;
          -  being pregnant or pregnancy in the preceding year&#xD;
&#xD;
          -  thoracic pain in the absence of neck or low back pain&#xD;
&#xD;
          -  diagnosed depression&#xD;
&#xD;
          -  BMI over 30&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Vrije Universiteit Brussel</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Neck 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/NCT03796481
org study id: EC/2018/0277/Amend
nct id: NCT03796481
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is focused on people with chronic spinal pain. To investigate the impact of sleep
      problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will
      be compared to 45 people with chronic spinal pain without insomnia.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Brief Pain Inventory (Numeric Rating Scale): Pain intensity
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
measure: Brief Pain Inventory: Pain Interference
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
measure: Central sensitization Inventory
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
measure: Pressure Pain Thresholds
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia).
measure: Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Participants will be monitored in the comfort of their own home by ambulatory polysomnography. This will provide the following parameters: time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging, sleep efficiency, sleep fragmentation, respiratory parameters, cardiac and myoclonic activity.
measure: Pittsburg Sleep Quality Index
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
measure: Insomnia Severity Index
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
measure: DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.
measure: Epworth Sleepiness Scale
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
measure: Brugmann Fatigue Scale
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
measure: Hospital Anxiety and Depression rating scale
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.
measure: Physical Activity using Actigraphy
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Physical activity: Continuous assessment of physical activity and rest/activity cycles
measure: Short Form Health Survey - 36 items Mental Health
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.
measure: Short Form Health Survey - 36 items Physical Health
time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
description: Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.
arm group label: Cases
description: People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia
arm group label: Controls
description: People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Low Back Pain
mesh term: Neck Pain