Clinical trial NCT03827174: Return to Work in Patients With Chronic Pain
Official title: Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Endometriosis
Keywords: Chronic pain
Endometriosis
Opioid therapy
Return to work
Vocational rehabilitation
Behavioural medicine
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: AFA Insurance
name: The Swedish Research Council
name: Uppsala County Council, Sweden
First posted: 2019-02-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Return to work
timeFrame: Number of days during a 12-month period from baseline to 12 months post baseline.
measure: Work ability
timeFrame: 12 months
Secondary outcomes:
measure: Work Ability
timeFrame: Baseline, 6 months, 24 months
measure: Return to work
timeFrame: Baseline, 6 months, 24 months
measure: Short-term sick leave < 2 weeks, number of days
timeFrame: 6 months, 12 months, 24 months
measure: Health-related quality of life: EQ-5D
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Opioid use
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Substance use disorder
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Pain severity: The Brief Pain Inventory
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Pain interference: The Brief Pain Inventory
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Balance
timeFrame: Baseline, 6 months, 12 months
measure: Functional lifting capacity
timeFrame: Baseline, 6 months, 12 months
measure: Grip strength
timeFrame: Baseline, 6 months, 12 months
measure: Catastrophizing
timeFrame: Baseline, 6 months, 12 months
measure: Fear of movement and reinjury
timeFrame: Baseline, 6 months, 12 months
measure: Psychological inflexibility in pain
timeFrame: Baseline, 6 months, 12 months
measure: Depressive symptoms
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Generalised Anxiety Disorder
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Experience of injustice
timeFrame: Baseline, 6 months, 12 months
measure: Cognitive function
timeFrame: Baseline, 6 months, 12 months
measure: Physical activity level
timeFrame: Baseline, 6 months, 12 months
measure: Sleep
timeFrame: Baseline, 6 months, 12 months
measure: Global goal achievement
timeFrame: 6 months, 12 months, 24 months
measure: Explorative identification of change in biomarkers
timeFrame: Changes from baseline to 6 months.
Other outcomes:
measure: Patient-specific goals for return to work
timeFrame: Baseline, 6 months, 12 months
measure: Self-efficacy to support return to work (employer): Number of items
timeFrame: Baseline, 6 months
measure: Number of participants who report adverse events associated with treatment
timeFrame: Up to 6 months
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppland
Study officials:
affiliation: Department of Neuroscience, Uppsala University
name: Pernilla Åsenlöf, Professor
role: PRINCIPAL_INVESTIGATOR
References: