Return to Work in Patients With Chronic Pain (UWORKin)

Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Endometriosis
• Intervention / Treatment: Other: Return To Work Coordination; Behavioral: Behaviour Change Ability Program

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pernilla Åsenlöf, Professor; Phone Number: +46704562831; Email: pernilla.asenlof@neuro.uu.se
• Study Contact Backup: Name: Hedvig Zetterberg, PhD-student; Phone Number: +46709845066; Email: hedvig.zetterberg@neuro.uu.se

Study Locations

• Sweden
  • Uppland
    • Uppsala, Uppland, Sweden, 75226
      • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	Average sick leave according to the Swedish Social Insurance registry, defined as net days.	Number of days during a 12-month period from baseline to 12 months post baseline.
Work ability	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Ability	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.	Baseline, 6 months, 24 months
Return to work	Average sick leave according to the Swedish Social Insurance registry, defined as net days.	Baseline, 6 months, 24 months
Short-term sick leave < 2 weeks, number of days	Self-reported number of days with sick-leave not exceeding two weeks	6 months, 12 months, 24 months
Health-related quality of life: EQ-5D	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).	Baseline, 6 months, 12 months, 24 months
Opioid use	Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.	Baseline, 6 months, 12 months, 24 months
Substance use disorder	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	Baseline, 6 months, 12 months, 24 months
Pain severity: The Brief Pain Inventory	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.	Baseline, 6 months, 12 months, 24 months
Pain interference: The Brief Pain Inventory	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.	Baseline, 6 months, 12 months, 24 months
Balance	The MiniBESTest	Baseline, 6 months, 12 months
Functional lifting capacity	Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test	Baseline, 6 months, 12 months
Grip strength	Dynamometer GRIPPIT (name of brand)	Baseline, 6 months, 12 months
Catastrophizing	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.	Baseline, 6 months, 12 months
Fear of movement and reinjury	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.	Baseline, 6 months, 12 months
Psychological inflexibility in pain	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.	Baseline, 6 months, 12 months
Depressive symptoms	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.	Baseline, 6 months, 12 months, 24 months
Generalised Anxiety Disorder	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.	Baseline, 6 months, 12 months, 24 months
Experience of injustice	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.	Baseline, 6 months, 12 months
Cognitive function	The Cambridge Neuropsychological Test Automated Battery (CANTAB): Spatial Working Memory, Paired Associates Learning, Delayed Match to Sample and Stocking of Cambridge (SOC).	Baseline, 6 months, 12 months
Physical activity level	Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.	Baseline, 6 months, 12 months
Sleep	Sleep pattern: Actigraph during night and days for one week.	Baseline, 6 months, 12 months
Global goal achievement	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'.	6 months, 12 months, 24 months
Explorative identification of change in biomarkers	Biomarkers will be explored by use of the OLINK (name of brand) panel which enables analysis of 92 inflammation-related protein biomarkers.	Changes from baseline to 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-specific goals for return to work	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.	Baseline, 6 months, 12 months
Self-efficacy to support return to work (employer): Number of items	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.	Baseline, 6 months
Number of participants who report adverse events associated with treatment	Adverse events will be measured with a study-specific diary including a check-list and open ended questions.	Up to 6 months

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: The Swedish Research Council; Uppsala University Hospital; Uppsala County Council, Sweden; AFA Insurance
• Investigators: Principal Investigator: Pernilla Åsenlöf, Professor, Department of Neuroscience, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic pain; Endometriosis; Vocational rehabilitation; Return to work; Opioid therapy; Behavioural medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Chronic Pain; Endometriosis
• Other Study ID Numbers: 160069 (AFA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No