<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/NCT02969434</url>
  </required_header>
  <id_info>
    <org_study_id>1/027/16</org_study_id>
    <nct_id>NCT02969434</nct_id>
  </id_info>
  <brief_title>Chronic Pain and Assessment of Sleep</brief_title>
  <official_title>Accuracy of the Brief Pain Inventory in Identifying Sleep Disturbances in Chronic Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Grampian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue&#xD;
      pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy,&#xD;
      improve both sleep quality and also pain management, and reduce interference of pain with&#xD;
      daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep&#xD;
      has been proposed as marker of effective pain management. Hence it is useful to evaluate&#xD;
      sleep disturbances in chronic pain population both in clinical and research setting. There&#xD;
      are many tools to evaluate sleep quality; the routinely used simple brief pain inventory&#xD;
      (BPI) has a single question about sleep. We will compare three dedicated sleep measures to&#xD;
      the BPI in patients with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of sleep disturbances including insomnia is high in chronic pain patients and&#xD;
      is known to contribute to the maintenance of chronic pain. A large survey estimated that&#xD;
      chronic pain of moderate to severe intensity occurs in 19% of adult Europeans, and that 50%&#xD;
      of this cohort reported feeling tired all the time. Studies using specific sleep assessment&#xD;
      tools have found that up to 50% of patients complain of poor sleep and 40% have clinically&#xD;
      defined insomnia.&#xD;
&#xD;
      Though association between sleep and pain is well established, it is still unclear about the&#xD;
      direction of causality. A recent narrative review has found that sleep impairments reliably&#xD;
      predict worsening of chronic pain and correlate with higher visual analogue pain scores.&#xD;
      Therapies targeted at improving sleep hygiene, including cognitive behavioral therapy, have&#xD;
      been shown to not only improve sleep quality, but also pain management and reduce the degree&#xD;
      to which pain interfered with daily activities. As effective pain relief decreases sleep&#xD;
      disturbances, improvement in sleep has been proposed as marker of effective pain management.8&#xD;
      Hence it is useful to evaluate sleep disturbances in chronic pain population both in clinical&#xD;
      and research setting.&#xD;
&#xD;
      There are at least 30 different sleep evaluation scales and questionnaires. Previous works&#xD;
      have used several different tools to quantify the prevalence and severity of sleep&#xD;
      disturbance in chronic pain patients. The most commonly used tools are the Pittsburgh Sleep&#xD;
      Quality Index (PSQI) and the Medical Outcomes Study (MOS) Sleep Scale. The PSQI has an&#xD;
      extensive body of evidence in detecting primary insomnia, demonstrating a high test-retest&#xD;
      reliability and contains domains which are of importance when measuring sleep disturbance in&#xD;
      chronic pain. However, none of the aforementioned tools directly assesses the impact of pain&#xD;
      on sleep, and are as such not capable of establishing a direct link between sleep disturbance&#xD;
      and chronic pain. Chronic Pain Sleep Inventory (CPSI) and Pain and Sleep Questionnaires (PSQ)&#xD;
      were developed to assess the impact of pain on pain related sleep disturbances. These&#xD;
      multidimensional items were abbreviated to Sleep Pain Index (SPI) and Pain and Sleep&#xD;
      three-item index (PSQ-3) and specifically targeted at assessing sleep disturbance in patients&#xD;
      with chronic pain. Both SPI and PSQ- 3 have been tested for their reliability and validity.&#xD;
      The Verran Snyder-Halpern (VSH) scale uses visual analogue scales to describe sleep quality,&#xD;
      latency and disturbance but none of these questionnaires have been widely adopted either in&#xD;
      research setting or clinical practice. Though the reasons are not known, people may find&#xD;
      multi-items dedicated questionnaires as cumbersome and overwhelming. One way to circumvent&#xD;
      the issue is to utilize a single item questionnaire or even use a single item on the widely&#xD;
      used pain questionnaire. Single item numerical rating scales to measure sleep quality have&#xD;
      shown modest correlation with the MOS sleep scale and may be of particular benefit when&#xD;
      repeated measurements are used due to their simple nature.&#xD;
&#xD;
      Brief Pain Inventory (BPI) is one of the most widely used measurement tool and is advocated&#xD;
      as one of the core outcomes tool for pain clinical trials. BPI provides an overall picture of&#xD;
      pain status and its interference with general health and serves to help monitor response to&#xD;
      treatment with time. Included in the BPI is a single numerically rated score assessing the&#xD;
      degree to which pain interferes with sleep. This item has the potential to detect the impact&#xD;
      of pain on pain related sleep disturbances thereby insomnia and therefore lead to treatment.&#xD;
      Validation of this commonly used questionnaire BPI, against a formal sleep assessment tools&#xD;
      would not only allow identification of patients with significant sleep disturbance and&#xD;
      facilitate prompt targeted treatment but also help to evaluate the pain treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">April 20, 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment of 50 patients</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Sleep questionnaires assessment tools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep assessment tools</intervention_name>
    <description>Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).</description>
    <arm_group_label>Sleep questionnaires assessment tools</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged 16 or over Chronic pain Fluent in English Able to report on their health and pain&#xD;
        status (neurologically stable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Under 16 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saravanakumar F Kanakarajan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Aberdeen/NHS Grampian</name>
      <address>
        <city>Aberdeen</city>
        <state>Scotland</state>
        <zip>AB25 2ZB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>April 20, 2017</last_update_submitted>
  <last_update_submitted_qc>April 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2017</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>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02969434
org study id: 1/027/16
nct id: NCT02969434
lead sponsor: 
collaborator: 
has dmc: No
Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue
      pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy,
      improve both sleep quality and also pain management, and reduce interference of pain with
      daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep
      has been proposed as marker of effective pain management. Hence it is useful to evaluate
      sleep disturbances in chronic pain population both in clinical and research setting. There
      are many tools to evaluate sleep quality; the routinely used simple brief pain inventory
      (BPI) has a single question about sleep. We will compare three dedicated sleep measures to
      the BPI in patients with chronic pain.
The prevalence of sleep disturbances including insomnia is high in chronic pain patients and
      is known to contribute to the maintenance of chronic pain. A large survey estimated that
      chronic pain of moderate to severe intensity occurs in 19% of adult Europeans, and that 50%
      of this cohort reported feeling tired all the time. Studies using specific sleep assessment
      tools have found that up to 50% of patients complain of poor sleep and 40% have clinically
      defined insomnia.

      Though association between sleep and pain is well established, it is still unclear about the
      direction of causality. A recent narrative review has found that sleep impairments reliably
      predict worsening of chronic pain and correlate with higher visual analogue pain scores.
      Therapies targeted at improving sleep hygiene, including cognitive behavioral therapy, have
      been shown to not only improve sleep quality, but also pain management and reduce the degree
      to which pain interfered with daily activities. As effective pain relief decreases sleep
      disturbances, improvement in sleep has been proposed as marker of effective pain management.8
      Hence it is useful to evaluate sleep disturbances in chronic pain population both in clinical
      and research setting.

      There are at least 30 different sleep evaluation scales and questionnaires. Previous works
      have used several different tools to quantify the prevalence and severity of sleep
      disturbance in chronic pain patients. The most commonly used tools are the Pittsburgh Sleep
      Quality Index (PSQI) and the Medical Outcomes Study (MOS) Sleep Scale. The PSQI has an
      extensive body of evidence in detecting primary insomnia, demonstrating a high test-retest
      reliability and contains domains which are of importance when measuring sleep disturbance in
      chronic pain. However, none of the aforementioned tools directly assesses the impact of pain
      on sleep, and are as such not capable of establishing a direct link between sleep disturbance
      and chronic pain. Chronic Pain Sleep Inventory (CPSI) and Pain and Sleep Questionnaires (PSQ)
      were developed to assess the impact of pain on pain related sleep disturbances. These
      multidimensional items were abbreviated to Sleep Pain Index (SPI) and Pain and Sleep
      three-item index (PSQ-3) and specifically targeted at assessing sleep disturbance in patients
      with chronic pain. Both SPI and PSQ- 3 have been tested for their reliability and validity.
      The Verran Snyder-Halpern (VSH) scale uses visual analogue scales to describe sleep quality,
      latency and disturbance but none of these questionnaires have been widely adopted either in
      research setting or clinical practice. Though the reasons are not known, people may find
      multi-items dedicated questionnaires as cumbersome and overwhelming. One way to circumvent
      the issue is to utilize a single item questionnaire or even use a single item on the widely
      used pain questionnaire. Single item numerical rating scales to measure sleep quality have
      shown modest correlation with the MOS sleep scale and may be of particular benefit when
      repeated measurements are used due to their simple nature.

      Brief Pain Inventory (BPI) is one of the most widely used measurement tool and is advocated
      as one of the core outcomes tool for pain clinical trials. BPI provides an overall picture of
      pain status and its interference with general health and serves to help monitor response to
      treatment with time. Included in the BPI is a single numerically rated score assessing the
      degree to which pain interferes with sleep. This item has the potential to detect the impact
      of pain on pain related sleep disturbances thereby insomnia and therefore lead to treatment.
      Validation of this commonly used questionnaire BPI, against a formal sleep assessment tools
      would not only allow identification of patients with significant sleep disturbance and
      facilitate prompt targeted treatment but also help to evaluate the pain treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Recruitment of 50 patients
time frame: 16 weeks
arm group label: Sleep questionnaires assessment tools
arm group type: Experimental
description: Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).
intervention type: Other
intervention name: Sleep assessment tools
description: Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).
arm group label: Sleep questionnaires assessment tools
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Saravanakumar F Kanakarajan
role: Principal Investigator
affiliation: University of Aberdeen
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No