Return to Work in Patients With Chronic Pain

NCT ID: NCT03827174

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2021-02-01

Brief Summary

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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

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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

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Chronic Pain Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The outcomes assessors are blinded to study condition during all measurements. Participants and providers of the return to work coordination intervention are blinded until a rehabilitation plan has been completed. Thereafter allocation to study condition is disclosed and the other components of the behaviour change ability programme are provided to those in the experimental group.

Study Groups

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Comparison intervention

Return To Work Coordination: external and internal coordination regarding sick leave. Establishment of a common return to work plan between employer and employee.

Group Type ACTIVE_COMPARATOR

Return To Work Coordination

Intervention Type OTHER

External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.

Experimental intervention

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

Group Type EXPERIMENTAL

Return To Work Coordination

Intervention Type OTHER

External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.

Behaviour Change Ability Program

Intervention Type BEHAVIORAL

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

Interventions

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Return To Work Coordination

External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.

Intervention Type OTHER

Behaviour Change Ability Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

AFA Insurance

INDUSTRY

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Pernilla Asenlof

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernilla Åsenlöf, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroscience, Uppsala University

Locations

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Uppsala University Hospital

Uppsala, Uppland, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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160069 (AFA)

Identifier Type: -

Identifier Source: org_study_id

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