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Return to Work in Patients With Chronic Pain (UWORKin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827174
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Uppsala University Hospital
AFA Insurance
The Swedish Research Council
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Pernilla Asenlof, Uppsala University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Endometriosis Other: Return To Work Coordination Behavioral: Behaviour Change Ability Program Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Comparison intervention
Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee.
Other: Return To Work Coordination
External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.

Experimental: Experimental intervention

Return To Work Coordination + Behaviour Change Ability Programme

Behaviour Change Ability Programme:

  1. Return to work coordination
  2. Education for employers and employees in pain neuroscience, validation, and problem-solving
  3. Patient specific goal setting for return to work
  4. Exercise and behavioural skills training related to return to work
Other: Return To Work Coordination
External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.

Behavioral: Behaviour Change Ability Program
  1. Return to work coordination
  2. Education for employers and employees in pain neuroscience, validation and problem-solving.
  3. Patient-specific goal setting for return to work
  4. Exercise and behavioural skills training related to return to work




Primary Outcome Measures :
  1. Return to work [ Time Frame: Number of days during a 12-month period from baseline to 12 months post baseline. ]
    Average sick leave according to the Swedish Social Insurance registry, defined as net days.

  2. Work ability [ Time Frame: 12 months ]

    Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:

    1. current work ability compared with lifetime best
    2. work ability in relation to the demands of the job
    3. number of diagnosed illnesses or limiting conditions
    4. estimated impairment owing to diseases/illnesses or limiting conditions
    5. amount of sick leave during the last year
    6. prognosis of work ability in 2 years' time
    7. psychological resources.

    The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.



Secondary Outcome Measures :
  1. Work Ability [ Time Frame: Baseline, 6 months, 24 months ]

    Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions:

    1. current work ability compared with lifetime best
    2. work ability in relation to the demands of the job
    3. number of diagnosed illnesses or limiting conditions
    4. estimated impairment owing to diseases/illnesses or limiting conditions
    5. amount of sick leave during the last year
    6. prognosis of work ability in 2 years' time
    7. psychological resources

    The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.


  2. Return to work [ Time Frame: Baseline, 6 months, 24 months ]
    Average sick leave according to the Swedish Social Insurance registry, defined as net days.

  3. Short-term sick leave < 2 weeks, number of days [ Time Frame: 6 months, 12 months, 24 months ]
    Self-reported number of days with sick-leave not exceeding two weeks

  4. Health-related quality of life: EQ-5D [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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).

  5. Opioid use [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.

  6. Substance use disorder [ Time Frame: Baseline, 6 months, 12 months, 24 months ]

    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


  7. Pain severity: The Brief Pain Inventory [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  8. Pain interference: The Brief Pain Inventory [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  9. Balance [ Time Frame: Baseline, 6 months, 12 months ]
    The MiniBESTest

  10. Functional lifting capacity [ Time Frame: Baseline, 6 months, 12 months ]
    Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test

  11. Grip strength [ Time Frame: Baseline, 6 months, 12 months ]
    Dynamometer GRIPPIT (name of brand)

  12. Catastrophizing [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  13. Fear of movement and reinjury [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  14. Psychological inflexibility in pain [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  15. Depressive symptoms [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  16. Generalised Anxiety Disorder [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  17. Experience of injustice [ Time Frame: Baseline, 6 months, 12 months ]

    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.


  18. Cognitive function [ Time Frame: Baseline, 6 months, 12 months ]
    The Cambridge Neuropsychological Test Automated Battery (CANTAB): Spatial Working Memory, Paired Associates Learning, Delayed Match to Sample and Stocking of Cambridge (SOC).

  19. Physical activity level [ Time Frame: Baseline, 6 months, 12 months ]
    Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.

  20. Sleep [ Time Frame: Baseline, 6 months, 12 months ]
    Sleep pattern: Actigraph during night and days for one week.

  21. Global goal achievement [ Time Frame: 6 months, 12 months, 24 months ]
    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'.

  22. Explorative identification of change in biomarkers [ Time Frame: Changes from baseline to 6 months. ]
    Biomarkers will be explored by use of the OLINK (name of brand) panel which enables analysis of 92 inflammation-related protein biomarkers.


Other Outcome Measures:
  1. Patient-specific goals for return to work [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  2. Self-efficacy to support return to work (employer): Number of items [ Time Frame: Baseline, 6 months ]
    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.

  3. Number of participants who report adverse events associated with treatment [ Time Frame: Up to 6 months ]
    Adverse events will be measured with a study-specific diary including a check-list and open ended questions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pain with a duration for more than 3 months
  • On sick-leave 25%-100% from salaried employment or studies, for at least 30 days
  • Identified employer or director of studies
  • Ability to understand, speak, and write Swedish

Exclusion Criteria:

  • Severe substance use disorder
  • Severe psychiatric illness
  • Recruited participants with employers who does not consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827174


Contacts
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Contact: Pernilla Åsenlöf, Professor +46704562831 pernilla.asenlof@neuro.uu.se
Contact: Hedvig Zetterberg, PhD-student +46709845066 hedvig.zetterberg@neuro.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Uppland, Sweden, 75226
Contact: Rolf Karlsten, PhD         
Principal Investigator: Pernilla Åsenlöf, PhD         
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
AFA Insurance
The Swedish Research Council
Uppsala County Council, Sweden
Investigators
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Principal Investigator: Pernilla Åsenlöf, Professor Department of Neuroscience, Uppsala University

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Responsible Party: Pernilla Asenlof, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT03827174    
Other Study ID Numbers: 160069 (AFA)
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pernilla Asenlof, Uppsala University:
Chronic pain
Endometriosis
Opioid therapy
Return to work
Vocational rehabilitation
Behavioural medicine
Additional relevant MeSH terms:
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Endometriosis
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Diseases, Female