Return to Work in Patients With Chronic Pain

NCT03827174 | Terminated

• 1 other identifier: 160069 (AFA)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Endometriosis

Keywords

Chronic pain; Endometriosis; Opioid therapy; Return to work; Vocational rehabilitation; Behavioural medicine

Outcome Measures

Primary Outcomes (2)

• Return to work

  Average sick leave according to the Swedish Social Insurance registry, defined as net days.

  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: 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.

  12 months

Secondary Outcomes (22)

• Work Ability

  Baseline, 6 months, 24 months

• Return to work

  Baseline, 6 months, 24 months

• Short-term sick leave < 2 weeks, number of days

  6 months, 12 months, 24 months

• Health-related quality of life: EQ-5D

  Baseline, 6 months, 12 months, 24 months

• Opioid use

  Baseline, 6 months, 12 months, 24 months

Other Outcomes (3)

• Patient-specific goals for return to work

  Baseline, 6 months, 12 months

• Self-efficacy to support return to work (employer): Number of items

  Baseline, 6 months

• Number of participants who report adverse events associated with treatment

  Up to 6 months

Study Arms (2)

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.

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

Other: Return To Work Coordination; Behavioral: Behaviour Change Ability Program

Interventions

Return To Work Coordination OTHER

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

Comparison intervention; Experimental intervention

Behaviour Change Ability Program 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

Experimental intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe substance use disorder
• Severe psychiatric illness
• Recruited participants with employers who does not consent to participate

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• AFA Insurance: collaborator
• The Swedish Research Council: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppland, 75226, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Endometriosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pernilla Åsenlöf, Professor

  Department of Neuroscience, Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 1, 2019
• Study Start: August 14, 2019
• Primary Completion: April 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

SE (1)