Return to Work in Patients With Chronic Pain

Chronic Pain Clinical Trial

— UWORKin  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03827174
• Other study ID #: 160069 (AFA)
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala	Uppland

Sponsors (5)

Lead Sponsor	Collaborator
Uppsala University	AFA Insurance, The Swedish Research Council, Uppsala County Council, Sweden, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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.
Primary	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	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
Secondary	Return to work	Average sick leave according to the Swedish Social Insurance registry, defined as net days.	Baseline, 6 months, 24 months
Secondary	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
Secondary	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
Secondary	Opioid use	Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.	Baseline, 6 months, 12 months, 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Balance	The MiniBESTest	Baseline, 6 months, 12 months
Secondary	Functional lifting capacity	Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test	Baseline, 6 months, 12 months
Secondary	Grip strength	Dynamometer GRIPPIT (name of brand)	Baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical activity level	Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.	Baseline, 6 months, 12 months
Secondary	Sleep	Sleep pattern: Actigraph during night and days for one week.	Baseline, 6 months, 12 months
Secondary	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
Secondary	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.