Chronic PainUWORKinNCT03827174
Return to Work in Patients With Chronic Pain
A study testing Return To Work Coordination and Behaviour Change Ability Program in people with Chronic Pain and Endometriosis, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Endometriosis
- What is being tested?
- Return To Work Coordination and Behaviour Change Ability Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 14 Aug 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe substance use disorder
- Severe psychiatric illness
- Recruited participants with employers who does not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Endometriosis
- Being tested
- Return To Work Coordination, Behaviour Change Ability Program
- Keywords
- Chronic pain, Endometriosis, Opioid therapy, Return to work, Vocational rehabilitation, Behavioural medicine
- Medical subject headings
- Chronic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return To Work CoordinationOther
External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.
Behaviour Change Ability ProgramBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Comparison intervention | Active comparator | Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee. Receives: Other: Return To Work Coordination |
| Experimental intervention | Experimental | 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 Receives: Other: Return To Work Coordination; Behavioral: Behaviour Change Ability Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Average sick leave according to the Swedish Social Insurance registry, defined as net days.
Measured: 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.
Measured: 12 months
Secondary outcomes (22)
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.
Measured: Baseline, 6 months, 24 months
Return to work
Average sick leave according to the Swedish Social Insurance registry, defined as net days.
Measured: 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
Measured: 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).
Measured: Baseline, 6 months, 12 months, 24 months
Opioid use
Interview: Time-Line-Follow-Back. 4-week recall regarding opioid medication yes/no and dose.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months, 24 months
Balance
The MiniBESTest
Measured: Baseline, 6 months, 12 months
Functional lifting capacity
Progressive Isoinertial Lifting Evaluation (PILE): cervical lifting test
Measured: Baseline, 6 months, 12 months
Grip strength
Dynamometer GRIPPIT (name of brand)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- Severity/irreparability by summing 1, 2, 4, 5, 6, 8.
Measured: 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).
Measured: Baseline, 6 months, 12 months
Physical activity level
Accelerometer during one week. Time spent in sedentary, low, moderate and vigorous physical activity.
Measured: Baseline, 6 months, 12 months
Sleep
Sleep pattern: Actigraph during night and days for one week.
Measured: 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'.
Measured: 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.
Measured: Changes from baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start14 Aug 2019
- Primary completion1 Apr 2020
- Study completion1 Feb 2021
Why it stopped: All clinicial studies were stopped during the Covid-19 pandemic. Interventions not possible to perform, neither at workplace nor at the gym.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, AFA Insurance, The Swedish Research Council, Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Pernilla Asenlof, Uppsala University
- Investigators
- Pernilla Åsenlöf, Professor, Principal investigator, Department of Neuroscience, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827174
- Sponsor's protocol ID
- 160069 (AFA)
- Acronym
- UWORKin
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03827174
- Acronym / sponsor ID
- UWORKin / 160069 (AFA)
- Conditions
- Chronic Pain, Endometriosis
- Keywords
- Chronic pain, Endometriosis, Opioid therapy, Return to work, Vocational rehabilitation, Behavioural medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All clinicial studies were stopped during the Covid-19 pandemic. Interventions not possible to perform, neither at workplace nor at the gym.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, AFA Insurance, The Swedish Research Council, Uppsala County Council, Sweden
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison intervention | Active comparator | Other: Return To Work CoordinationReturn To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee. |
| Experimental intervention | Experimental | Other: Return To Work Coordination, Behavioral: Behaviour Change Ability ProgramReturn 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Severe substance use disorder
- Severe psychiatric illness
- Recruited participants with employers who does not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Return To Work CoordinationExternal and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee. | Other | Comparison intervention, Experimental intervention |
| Behaviour Change Ability Program1. 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 | Behavioural | Experimental intervention |
Primary outcome
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.
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.
22 secondary outcomes
Work Ability
Time frame: Baseline, 6 months, 24 months
Return to work
Time frame: Baseline, 6 months, 24 months
Short-term sick leave < 2 weeks, number of days
Time frame: 6 months, 12 months, 24 months
Health-related quality of life: EQ-5D
Time frame: Baseline, 6 months, 12 months, 24 months
Opioid use
Time frame: Baseline, 6 months, 12 months, 24 months
Substance use disorder
Time frame: Baseline, 6 months, 12 months, 24 months
Pain severity: The Brief Pain Inventory
Time frame: Baseline, 6 months, 12 months, 24 months
Pain interference: The Brief Pain Inventory
Time frame: Baseline, 6 months, 12 months, 24 months
Balance
Time frame: Baseline, 6 months, 12 months
Functional lifting capacity
Time frame: Baseline, 6 months, 12 months
Grip strength
Time frame: Baseline, 6 months, 12 months
Catastrophizing
Time frame: Baseline, 6 months, 12 months
Fear of movement and reinjury
Time frame: Baseline, 6 months, 12 months
Psychological inflexibility in pain
Time frame: Baseline, 6 months, 12 months
Depressive symptoms
Time frame: Baseline, 6 months, 12 months, 24 months
Generalised Anxiety Disorder
Time frame: Baseline, 6 months, 12 months, 24 months
Experience of injustice
Time frame: Baseline, 6 months, 12 months
Cognitive function
Time frame: Baseline, 6 months, 12 months
Physical activity level
Time frame: Baseline, 6 months, 12 months
Sleep
Time frame: Baseline, 6 months, 12 months
Global goal achievement
Time frame: 6 months, 12 months, 24 months
Explorative identification of change in biomarkers
Time frame: Changes from baseline to 6 months.
Results and safety
The study was stopped early (reason given: All clinicial studies were stopped during the Covid-19 pandemic. Interventions not possible to perform, neither at workplace nor at the gym.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Åsenlöf, Professor principal investigator
Department of Neuroscience, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return To Work Coordination and Behaviour Change Ability Program in people with Chronic Pain and Endometriosis, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All clinicial studies were stopped during the Covid-19 pandemic. Interventions not possible to perform, neither at workplace nor at the gym.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: Number of days during a 12-month period from baseline to 12 months post baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.