<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/NCT03827174</url>
  </required_header>
  <id_info>
    <org_study_id>160069 (AFA)</org_study_id>
    <nct_id>NCT03827174</nct_id>
  </id_info>
  <brief_title>Return to Work in Patients With Chronic Pain</brief_title>
  <acronym>UWORKin</acronym>
  <official_title>Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AFA Insurance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Swedish Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uppsala County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uppsala 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>
      This study aims to evaluate whether a vocational behaviour change ability programme has any&#xD;
      additional effect on return to work compared with return to work coordination only in persons&#xD;
      with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      New vocational rehabilitation models including the workplace are urgently needed for persons&#xD;
      with chronic pain.&#xD;
&#xD;
      Return to work coordination means external and internal coordination regarding sick leave by&#xD;
      help of a rehabilitation coordinator from health care. The goal is to establish a common&#xD;
      return to work plan between employer and employee as dictated by Swedish law. The hypothesis&#xD;
      is that return to work coordination is not sufficient. Additional effects on return to work&#xD;
      and work ability from a behaviour change ability programme aiming to enhance work ability by&#xD;
      targeting context at the workplace, physical and psychological functioning, and behavioral&#xD;
      skills at work are expected.&#xD;
&#xD;
      The hypothesis is tested in a randomised controlled trial. Before the start of the trial a&#xD;
      series of 3-6 experimental single case studies will be performed to study the implementation&#xD;
      of the interventions more thoroughly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 14, 2019</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The outcomes assessors are blinded to study condition during all measurements. Participants and providers of the return to work coordination intervention are blinded until a rehabilitation plan has been completed. Thereafter allocation to study condition is disclosed and the other components of the behaviour change ability programme are provided to those in the experimental group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Return to work</measure>
    <time_frame>Number of days during a 12-month period from baseline to 12 months post baseline.</time_frame>
    <description>Average sick leave according to the Swedish Social Insurance registry, defined as net days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work ability</measure>
    <time_frame>12 months</time_frame>
    <description>Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:&#xD;
current work ability compared with lifetime best&#xD;
work ability in relation to the demands of the job&#xD;
number of diagnosed illnesses or limiting conditions&#xD;
estimated impairment owing to diseases/illnesses or limiting conditions&#xD;
amount of sick leave during the last year&#xD;
prognosis of work ability in 2 years' time&#xD;
psychological resources.&#xD;
The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Work Ability</measure>
    <time_frame>Baseline, 6 months, 24 months</time_frame>
    <description>Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:&#xD;
current work ability compared with lifetime best&#xD;
work ability in relation to the demands of the job&#xD;
number of diagnosed illnesses or limiting conditions&#xD;
estimated impairment owing to diseases/illnesses or limiting conditions&#xD;
amount of sick leave during the last year&#xD;
prognosis of work ability in 2 years' time&#xD;
psychological resources&#xD;
The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>Baseline, 6 months, 24 months</time_frame>
    <description>Average sick leave according to the Swedish Social Insurance registry, defined as net days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-term sick leave &lt; 2 weeks, number of days</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>Self-reported number of days with sick-leave not exceeding two weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life: EQ-5D</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Self-report. The EuroQoL - Five dimension (EQ-5D). The five dimensions are: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each scales ranges from 0 to 2, where a low score indicates better health. The EQ-5D questionnaire also includes a visual analog scale where perceived health status is rated with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid use</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance use disorder</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Interview: Mini International Neuropsychiatric Interview, Part J (Substance use). Response format yes/no.&#xD;
Mild substance use disorder = 2-3 symptoms Moderate substance use disorder = 4-5 symptoms Severe substance use disorder = 6 or more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity: The Brief Pain Inventory</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Self-report. The Brief Pain Inventory. Severity is measured with 4 items where worst, least, average, and current pain during the past week are scored. Each scale ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'. Each of the severity scales will be presented separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference: The Brief Pain Inventory</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Self-report. The Brief Pain Inventory. Interference is measured with 7 items (general activity, mood, working ability, normal work, relations with other people, sleep, and enjoyment of life). Each scale ranges from 0 to 10, where 0 ='does not interfere', and 10 = 'completely interferes'. Interference is scored as the mean of the seven interference items. Higher scores indicate higher pain interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>The MiniBESTest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional lifting capacity</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Dynamometer GRIPPIT (name of brand)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophizing</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Self-report, The Pain Catastrophizing Scale (PCS) - Swedish version. 13 items, ranging from 0 to 4 where 0 = 'not at all', 4 = 'all the time'. A total score is calculated ranging from 0 to 52 where higher scores indicate higher catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement and reinjury</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Self-report, The Tampa Scale of Kinesiophobia-11 (TSK-11), Swedish version. 11 items ranging from 1 to 4 where 1 = 'does not agree at all', 4 = 'totally agree'. A total score is calculated ranging from 11 to 44 where higher scores indicate higher fear of movement/kinesiophobia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological inflexibility in pain</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Self-report. Psychological inflexibility in pain (PIPS) is a 12-item scale used to assess psychological inflexibility (i.e. avoidance, acceptance, fusion, values orientation, dirty discomfort) in people with chronic pain. Two main components are measured: 1) Avoidance of pain (items: 1,2,4,5,7,8,10,11), 2) Fusion with pain thoughts (items: 3,6,9,12) Scoring: Respondents are asked to rate items on a 7-point scale that ranges from 1= 'never true' to 7 = 'always true'. Scores are summed to a total score and to two subscale scores. Higher scores indicate greater levels of psychological inflexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Self-report: Patient Health Questionnaire - 9 (PHQ-9), Swedish version. 9 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. The first 9 items are summed to a sum score ranging from 0 to 27, where: 0-4 = no signs of depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression. Item 10 is reported as a single item where high scores indicate high interference with daily function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalised Anxiety Disorder</measure>
    <time_frame>Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Self-report: Generalised Anxiety Disorder (GAD-7). 7 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. 1 item ranging from 0 ='not at all, to 3 = 'very disturbing'. The first 7 items are summed to a sum score ranging from 0 to 21, where: 0-4 = no signs of anxiety, 5-9 = mild GAD, 10-14 = moderate GAD, 15-21 = severe GAD. Item 8 is reported as a single item where higher score means higher interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience of injustice</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Self-report: Injustice Experience Questionnaire (IEQ), Swedish version. 12 items ranging from 0 ='never, to 4 ='all the time'. A total score is computed by summing the scores to all 12 items, ranging from 0-48 where higher scores indicate higher experience of injustice.&#xD;
Two subscales is used. 1) Blame/unfairness by summing items 3, 7, 9, 10, 11, 23.&#xD;
2) Severity/irreparability by summing 1, 2, 4, 5, 6, 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>The Cambridge Neuropsychological Test Automated Battery (CANTAB): Spatial Working Memory, Paired Associates Learning, Delayed Match to Sample and Stocking of Cambridge (SOC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Sleep pattern: Actigraph during night and days for one week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global goal achievement</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>Self-report. Patient global impression of change (PGIC). The measure reflects participant's beliefs about the efficacy of treatment. The patient rates overall improvement on a 7-point scale where 3 = 'very much improved', 2 = 'much improved', 1 = 'minimally improved', 0 = 'no change', -1 = 'minimally worse', -2 = 'much worse', and -3 ='very much worse'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explorative identification of change in biomarkers</measure>
    <time_frame>Changes from baseline to 6 months.</time_frame>
    <description>Biomarkers will be explored by use of the OLINK (name of brand) panel which enables analysis of 92 inflammation-related protein biomarkers.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-specific goals for return to work</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Patient Goal Priority Questionnaire (PGPQ-WORK). Patient-specific questionnaire where the participant list 1-3 work-related activities that he or she wish to be able to perform better as a result of treatment. Activity, self-efficacy, fear of performance, and expected outcome level is then rated for each activity separately on 4 11-point numerical rating scales where higher scores indicate worse outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-efficacy to support return to work (employer): Number of items</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Study specific questions regarding the employer's self-efficacy to support the employee to return to work. Number of items is tied to individual process analysis of what is required to return to work in each specific case.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants who report adverse events associated with treatment</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Adverse events will be measured with a study-specific diary including a check-list and open ended questions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Comparison intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Return To Work Coordination + Behaviour Change Ability Programme&#xD;
Behaviour Change Ability Programme:&#xD;
Return to work coordination&#xD;
Education for employers and employees in pain neuroscience, validation, and problem-solving&#xD;
Patient specific goal setting for return to work&#xD;
Exercise and behavioural skills training related to return to work</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Return To Work Coordination</intervention_name>
    <description>External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.</description>
    <arm_group_label>Comparison intervention</arm_group_label>
    <arm_group_label>Experimental intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behaviour Change Ability Program</intervention_name>
    <description>Return to work coordination&#xD;
Education for employers and employees in pain neuroscience, validation and problem-solving.&#xD;
Patient-specific goal setting for return to work&#xD;
Exercise and behavioural skills training related to return to work</description>
    <arm_group_label>Experimental intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pain with a duration for more than 3 months&#xD;
&#xD;
          -  On sick-leave 25%-100% from salaried employment or studies, for at least 30 days&#xD;
&#xD;
          -  Identified employer or director of studies&#xD;
&#xD;
          -  Ability to understand, speak, and write Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe substance use disorder&#xD;
&#xD;
          -  Severe psychiatric illness&#xD;
&#xD;
          -  Recruited participants with employers who does not consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pernilla Åsenlöf, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neuroscience, Uppsala University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pernilla Åsenlöf, Professor</last_name>
    <phone>+46704562831</phone>
    <email>pernilla.asenlof@neuro.uu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hedvig Zetterberg, PhD-student</last_name>
    <phone>+46709845066</phone>
    <email>hedvig.zetterberg@neuro.uu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <state>Uppland</state>
        <zip>75226</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rolf Karlsten, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Pernilla Åsenlöf, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University</investigator_affiliation>
    <investigator_full_name>Pernilla Asenlof</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Endometriosis</keyword>
  <keyword>Opioid therapy</keyword>
  <keyword>Return to work</keyword>
  <keyword>Vocational rehabilitation</keyword>
  <keyword>Behavioural medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.</ipd_description>
  </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/NCT03827174
org study id: 160069 (AFA)
nct id: NCT03827174
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate whether a vocational behaviour change ability programme has any
      additional effect on return to work compared with return to work coordination only in persons
      with chronic pain.
New vocational rehabilitation models including the workplace are urgently needed for persons
      with chronic pain.

      Return to work coordination means external and internal coordination regarding sick leave by
      help of a rehabilitation coordinator from health care. The goal is to establish a common
      return to work plan between employer and employee as dictated by Swedish law. The hypothesis
      is that return to work coordination is not sufficient. Additional effects on return to work
      and work ability from a behaviour change ability programme aiming to enhance work ability by
      targeting context at the workplace, physical and psychological functioning, and behavioral
      skills at work are expected.

      The hypothesis is tested in a randomised controlled trial. Before the start of the trial a
      series of 3-6 experimental single case studies will be performed to study the implementation
      of the interventions more thoroughly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The outcomes assessors are blinded to study condition during all measurements. Participants and providers of the return to work coordination intervention are blinded until a rehabilitation plan has been completed. Thereafter allocation to study condition is disclosed and the other components of the behaviour change ability programme are provided to those in the experimental group.
measure: Return to work
time frame: Number of days during a 12-month period from baseline to 12 months post baseline.
description: Average sick leave according to the Swedish Social Insurance registry, defined as net days.
measure: Work ability
time frame: 12 months
description: Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:
current work ability compared with lifetime best
work ability in relation to the demands of the job
number of diagnosed illnesses or limiting conditions
estimated impairment owing to diseases/illnesses or limiting conditions
amount of sick leave during the last year
prognosis of work ability in 2 years' time
psychological resources.
The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.
measure: Work Ability
time frame: Baseline, 6 months, 24 months
description: Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:
current work ability compared with lifetime best
work ability in relation to the demands of the job
number of diagnosed illnesses or limiting conditions
estimated impairment owing to diseases/illnesses or limiting conditions
amount of sick leave during the last year
prognosis of work ability in 2 years' time
psychological resources
The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.
measure: Return to work
time frame: Baseline, 6 months, 24 months
description: Average sick leave according to the Swedish Social Insurance registry, defined as net days.
measure: Short-term sick leave < 2 weeks, number of days
time frame: 6 months, 12 months, 24 months
description: Self-reported number of days with sick-leave not exceeding two weeks
measure: Health-related quality of life: EQ-5D
time frame: Baseline, 6 months, 12 months, 24 months
description: Self-report. The EuroQoL - Five dimension (EQ-5D). The five dimensions are: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each scales ranges from 0 to 2, where a low score indicates better health. The EQ-5D questionnaire also includes a visual analog scale where perceived health status is rated with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
measure: Opioid use
time frame: Baseline, 6 months, 12 months, 24 months
description: Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.
measure: Substance use disorder
time frame: Baseline, 6 months, 12 months, 24 months
description: Interview: Mini International Neuropsychiatric Interview, Part J (Substance use). Response format yes/no.
Mild substance use disorder = 2-3 symptoms Moderate substance use disorder = 4-5 symptoms Severe substance use disorder = 6 or more symptoms
measure: Pain severity: The Brief Pain Inventory
time frame: Baseline, 6 months, 12 months, 24 months
description: Self-report. The Brief Pain Inventory. Severity is measured with 4 items where worst, least, average, and current pain during the past week are scored. Each scale ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'. Each of the severity scales will be presented separately.
measure: Pain interference: The Brief Pain Inventory
time frame: Baseline, 6 months, 12 months, 24 months
description: Self-report. The Brief Pain Inventory. Interference is measured with 7 items (general activity, mood, working ability, normal work, relations with other people, sleep, and enjoyment of life). Each scale ranges from 0 to 10, where 0 ='does not interfere', and 10 = 'completely interferes'. Interference is scored as the mean of the seven interference items. Higher scores indicate higher pain interference.
measure: Balance
time frame: Baseline, 6 months, 12 months
description: The MiniBESTest
measure: Functional lifting capacity
time frame: Baseline, 6 months, 12 months
description: Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test
measure: Grip strength
time frame: Baseline, 6 months, 12 months
description: Dynamometer GRIPPIT (name of brand)
measure: Catastrophizing
time frame: Baseline, 6 months, 12 months
description: Self-report, The Pain Catastrophizing Scale (PCS) - Swedish version. 13 items, ranging from 0 to 4 where 0 = 'not at all', 4 = 'all the time'. A total score is calculated ranging from 0 to 52 where higher scores indicate higher catastrophizing.
measure: Fear of movement and reinjury
time frame: Baseline, 6 months, 12 months
description: Self-report, The Tampa Scale of Kinesiophobia-11 (TSK-11), Swedish version. 11 items ranging from 1 to 4 where 1 = 'does not agree at all', 4 = 'totally agree'. A total score is calculated ranging from 11 to 44 where higher scores indicate higher fear of movement/kinesiophobia.
measure: Psychological inflexibility in pain
time frame: Baseline, 6 months, 12 months
description: Self-report. Psychological inflexibility in pain (PIPS) is a 12-item scale used to assess psychological inflexibility (i.e. avoidance, acceptance, fusion, values orientation, dirty discomfort) in people with chronic pain. Two main components are measured: 1) Avoidance of pain (items: 1,2,4,5,7,8,10,11), 2) Fusion with pain thoughts (items: 3,6,9,12) Scoring: Respondents are asked to rate items on a 7-point scale that ranges from 1= 'never true' to 7 = 'always true'. Scores are summed to a total score and to two subscale scores. Higher scores indicate greater levels of psychological inflexibility.
measure: Depressive symptoms
time frame: Baseline, 6 months, 12 months, 24 months
description: Self-report: Patient Health Questionnaire - 9 (PHQ-9), Swedish version. 9 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. The first 9 items are summed to a sum score ranging from 0 to 27, where: 0-4 = no signs of depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression. Item 10 is reported as a single item where high scores indicate high interference with daily function.
measure: Generalised Anxiety Disorder
time frame: Baseline, 6 months, 12 months, 24 months
description: Self-report: Generalised Anxiety Disorder (GAD-7). 7 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. 1 item ranging from 0 ='not at all, to 3 = 'very disturbing'. The first 7 items are summed to a sum score ranging from 0 to 21, where: 0-4 = no signs of anxiety, 5-9 = mild GAD, 10-14 = moderate GAD, 15-21 = severe GAD. Item 8 is reported as a single item where higher score means higher interference.
measure: Experience of injustice
time frame: Baseline, 6 months, 12 months
description: Self-report: Injustice Experience Questionnaire (IEQ), Swedish version. 12 items ranging from 0 ='never, to 4 ='all the time'. A total score is computed by summing the scores to all 12 items, ranging from 0-48 where higher scores indicate higher experience of injustice.
Two subscales is used. 1) Blame/unfairness by summing items 3, 7, 9, 10, 11, 23.
2) Severity/irreparability by summing 1, 2, 4, 5, 6, 8.
measure: Cognitive function
time frame: Baseline, 6 months, 12 months
description: The Cambridge Neuropsychological Test Automated Battery (CANTAB): Spatial Working Memory, Paired Associates Learning, Delayed Match to Sample and Stocking of Cambridge (SOC).
measure: Physical activity level
time frame: Baseline, 6 months, 12 months
description: Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.
measure: Sleep
time frame: Baseline, 6 months, 12 months
description: Sleep pattern: Actigraph during night and days for one week.
measure: Global goal achievement
time frame: 6 months, 12 months, 24 months
description: Self-report. Patient global impression of change (PGIC). The measure reflects participant's beliefs about the efficacy of treatment. The patient rates overall improvement on a 7-point scale where 3 = 'very much improved', 2 = 'much improved', 1 = 'minimally improved', 0 = 'no change', -1 = 'minimally worse', -2 = 'much worse', and -3 ='very much worse'.
measure: Explorative identification of change in biomarkers
time frame: Changes from baseline to 6 months.
description: Biomarkers will be explored by use of the OLINK (name of brand) panel which enables analysis of 92 inflammation-related protein biomarkers.
measure: Patient-specific goals for return to work
time frame: Baseline, 6 months, 12 months
description: Patient Goal Priority Questionnaire (PGPQ-WORK). Patient-specific questionnaire where the participant list 1-3 work-related activities that he or she wish to be able to perform better as a result of treatment. Activity, self-efficacy, fear of performance, and expected outcome level is then rated for each activity separately on 4 11-point numerical rating scales where higher scores indicate worse outcomes.
measure: Self-efficacy to support return to work (employer): Number of items
time frame: Baseline, 6 months
description: Study specific questions regarding the employer's self-efficacy to support the employee to return to work. Number of items is tied to individual process analysis of what is required to return to work in each specific case.
measure: Number of participants who report adverse events associated with treatment
time frame: Up to 6 months
description: Adverse events will be measured with a study-specific diary including a check-list and open ended questions.
arm group label: Comparison intervention
arm group type: Active Comparator
description: Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee.
arm group label: Experimental intervention
arm group type: Experimental
description: Return To Work Coordination + Behaviour Change Ability Programme
Behaviour Change Ability Programme:
Return to work coordination
Education for employers and employees in pain neuroscience, validation, and problem-solving
Patient specific goal setting for return to work
Exercise and behavioural skills training related to return to work
intervention type: Other
intervention name: Return To Work Coordination
description: External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.
arm group label: Comparison intervention
arm group label: Experimental intervention
intervention type: Behavioral
intervention name: Behaviour Change Ability Program
description: Return to work coordination
Education for employers and employees in pain neuroscience, validation and problem-solving.
Patient-specific goal setting for return to work
Exercise and behavioural skills training related to return to work
arm group label: Experimental intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pernilla Åsenlöf, Professor
role: Principal Investigator
affiliation: Department of Neuroscience, Uppsala University
last name: Pernilla Åsenlöf, Professor
phone: +46704562831
email: pernilla.asenlof@neuro.uu.se
last name: Hedvig Zetterberg, PhD-student
phone: +46709845066
email: hedvig.zetterberg@neuro.uu.se
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Uppsala University
investigator full name: Pernilla Asenlof
investigator title: Professor
mesh term: Endometriosis
mesh term: Chronic Pain
sharing ipd: Undecided
ipd description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.