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Clinical Trials/NCT03827174
NCT03827174
Terminated
Not Applicable

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

Uppsala University1 site in 1 country8 target enrollmentAugust 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Uppsala University
Enrollment
8
Locations
1
Primary Endpoint
Return to work
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2019
End Date
February 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Principal Investigator
Principal Investigator

Pernilla Asenlof

Professor

Uppsala University

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Short-term sick leave < 2 weeks, number of days(6 months, 12 months, 24 months)
  • Work Ability(Baseline, 6 months, 24 months)
  • Return to work(Baseline, 6 months, 24 months)
  • Opioid use(Baseline, 6 months, 12 months, 24 months)
  • Pain interference: The Brief Pain Inventory(Baseline, 6 months, 12 months, 24 months)
  • Health-related quality of life: EQ-5D(Baseline, 6 months, 12 months, 24 months)
  • Substance use disorder(Baseline, 6 months, 12 months, 24 months)
  • Pain severity: The Brief Pain Inventory(Baseline, 6 months, 12 months, 24 months)
  • Balance(Baseline, 6 months, 12 months)
  • Functional lifting capacity(Baseline, 6 months, 12 months)
  • Fear of movement and reinjury(Baseline, 6 months, 12 months)
  • Experience of injustice(Baseline, 6 months, 12 months)
  • Physical activity level(Baseline, 6 months, 12 months)
  • Catastrophizing(Baseline, 6 months, 12 months)
  • Depressive symptoms(Baseline, 6 months, 12 months, 24 months)
  • Generalised Anxiety Disorder(Baseline, 6 months, 12 months, 24 months)
  • Grip strength(Baseline, 6 months, 12 months)
  • Psychological inflexibility in pain(Baseline, 6 months, 12 months)
  • Sleep(Baseline, 6 months, 12 months)
  • Global goal achievement(6 months, 12 months, 24 months)
  • Explorative identification of change in biomarkers(Changes from baseline to 6 months.)
  • Cognitive function(Baseline, 6 months, 12 months)

Study Sites (1)

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