Return to Work in Patients With Chronic Pain
- Conditions
- EndometriosisChronic Pain
- Interventions
- Other: Return To Work CoordinationBehavioral: Behaviour Change Ability Program
- Registration Number
- NCT03827174
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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
- Severe substance use disorder
- Severe psychiatric illness
- Recruited participants with employers who does not consent to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparison intervention Return To Work Coordination Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee. Experimental intervention Return To Work Coordination 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 Experimental intervention Behaviour Change Ability Program 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
- Primary Outcome Measures
Name Time Method Return to work 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.
Work ability 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
Name Time Method Short-term sick leave < 2 weeks, number of days 6 months, 12 months, 24 months Self-reported number of days with sick-leave not exceeding two weeks
Work Ability 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.Return to work Baseline, 6 months, 24 months Average sick leave according to the Swedish Social Insurance registry, defined as net days.
Opioid use Baseline, 6 months, 12 months, 24 months Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.
Pain interference: The Brief Pain Inventory 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.
Health-related quality of life: EQ-5D 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).
Substance use disorder 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 symptomsPain severity: The Brief Pain Inventory 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.
Balance Baseline, 6 months, 12 months The MiniBESTest
Functional lifting capacity Baseline, 6 months, 12 months Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test
Fear of movement and reinjury 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.
Experience of injustice 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.Physical activity level Baseline, 6 months, 12 months Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.
Catastrophizing 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.
Depressive symptoms 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.
Generalised Anxiety Disorder 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.
Grip strength Baseline, 6 months, 12 months Dynamometer GRIPPIT (name of brand)
Psychological inflexibility in pain 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.
Sleep Baseline, 6 months, 12 months Sleep pattern: Actigraph during night and days for one week.
Global goal achievement 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'.
Explorative identification of change in biomarkers 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.
Cognitive function 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).
Trial Locations
- Locations (1)
Uppsala University Hospital
🇸🇪Uppsala, Uppland, Sweden