WorkUp. Structured Care With Workplace Interventions to Improve Work Ability in Patients With Neck and/or Low Back Pain (WorkUp)

December 13, 2023 updated by: Lund University

WorkUp. Early Structured Care Including Workplace Interventions to Improve Work Ability in Patients With Neck and/or Back Pain. A Prospective Pare Wise Cluster Randomized Controlled Trial in Primary Care With One Year Follow up

WorkUp is a prospective cluster randomised controlled trial in primary care. The main purpose is to investigate effects of early structured care based on screening of red flags (signs of serious medical conditions/disease), yellow flags (psychosocial factors, attitude to pain) and blue flags (workplace related factors) and including a workplace intervention according to the method "Convergence Dialogue Meetings" (CDM) for improving work ability, in comparison with treatment as usual, in patients with neck and/or back pain.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Musculoskeletal disorders are the most common reasons for sick leave in western countries. Identifying risk factors and predictors for a stable return to work (RTW ) is essential. An evidence-based safe care includes systems for detecting medical conditions with urgent need for care (red flags) and psycho-social risk factors (yellow flags). To maintain work ability, also requires different capacities related to work demands, (physical, mental and social) as well as work environment aspects covered by a "blue flag system".

Since motivation is assumed to drive and sustain human behaviour, patients with back pain seek health care when motivation reaches a threshold level. Patients want to be examined, get treatment and self-care advice to resume normal daily activities. This might lead to improved long-standing results in terms of health, function and work ability.

The investigators hypothesize that WorkUp, a timely tailor-made and evidence-based intervention leads to a faster recovery of health, function and RTW as compared to standard care. This includes the identification of both the patient's risk factors (red, yellow and blue flags) and motivational factors. Based on this screening, a structured tailored intervention will be offered. The WorkUp model comprise of evidence-based treatment and interaction between patient, health care and work place interventions.

The main purpose is to test WorkUp in a comparison study with treatment as usual (TAU) in primary health care (PHC).

Design: A prospective paire wise cluster randomized trial in PHC including a one year clinical follow-up and a three year register follow-up.

Intervention: Through a flow chart the investigators in detail specify the medical and work place interventions (all according to evidence-based guidelines). Red, yellow and blue flags, and motivational factors are identified in a screening investigation. The aim of the screening is to individually tailor the rehabilitation interventions. Physiotherapy interventions are based on a bio-psychosocial and cognitive behavioural therapy perspective. Behavioural medicine treatment principles will include careful examination and treatments such as advice to stay active, instructions, OMI, OMT, MDT. The investigators apply interventions based on ergonomics, motivational factors and work place changes according to Convergence Dialogue Meetings(CDM). CDM is a three step structured dialogue and meeting model supporting the patient, health care professionals and employer to summarize concrete suggestions to support a RTW .

TAU patients follow the PHC's standard schedule and procedures including the so called rehabilitation guarantee.

For each patient all treatment measures are recorded in a protocol.

A power analysis indicated that the investigators needed to recruit a minimum of 20 PHCs and 500 patients.

This type of structured routine primary care can facilitate an adequate treatment for patients with musculoskeletal pain and how to allocate sparse resources. If beneficial results emerge a structured implementation program will follow.

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • acute and subacute neck and/or back pain (less than three months of duration)
  • a working history of at least four weeks during the last year
  • being at risk for sick leave according to the short form of the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) (cut off >40)
  • if sickness absent < 60 days.

Exclusion Criteria:

  • identified abuse
  • retirement pension
  • ongoing acute medical treatment
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured care & workplace intervention
Through a flow chart the investigators in detail specify the medical and work place interventions (all according to evidence-based guidelines). Red, yellow and blue flags, and motivational factors are identified in a screening investigation. The aim of the screening is to individually tailor the rehabilitation interventions. Physiotherapy interventions are based on a bio-psychosocial and cognitive behavioural therapy perspective. Behavioural medicine treatment principles include careful examination and treatments such as advice to stay active, instructions, OMI, OMT, MDT. The investigators apply interventions based on ergonomics, motivational factors and work place changes according to Convergence Dialogue Meetings (CDM).
Other: Structured care & workplace intervention
In addition to structured care a workplace intervention named Convergence Dialogue Meetings (CDM) are carried out. CDM is a three step structured dialogue and meeting model supporting the patient, health care professionals and employer to summarize concrete suggestions to support sustainable work ability and a return to work if sick listed.
Active Comparator: Treatment as Usual
Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee
Other: Treatment as Usual
Patients will follow the primary health care's standard time schedule and procedures as of ordinary care and the rehabilitation guarantee. For each patient all treatment measures are recorded in a manual, regarding number of treatments, time used per treatment and type of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work ability
Time Frame: Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)
Work ability (defined as being at work or being eligible to the labour market during at least four weeks in a row) and time of sickness absence and Return to work. Year 2 and 3 follow-up by register data
Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Changes from baseline to after treatment (3, 6 and 12 months)
Measured by EQ-5D (Euroqol 2011 EQ-5D)
Changes from baseline to after treatment (3, 6 and 12 months)
Functional ability
Time Frame: Changes from baseline to after treatment (3, 6 and 12 months)
Measured by the Oswestry Disability Index (ODI) in low back pain patients (Fairbank & Pynsent 2000) and by the Neck Disability Index (NDI) in patients with neck pain (MacDermid et al 2009)
Changes from baseline to after treatment (3, 6 and 12 months)
Pain (distribution and intensity)
Time Frame: Changes from baseline to after treatment (3, 6 and 12 months)
Measured by the Pain mannequin (Bergman et al 2001) and VAS (Sieper et al 2009)
Changes from baseline to after treatment (3, 6 and 12 months)
Physical and psycho-social work environment
Time Frame: Changes from baseline to after treatment (3, 6 and 12 months)
Measured by questions focusing on known risk factors according to Lindell´s thesis (2010) and the ULF questionnaire
Changes from baseline to after treatment (3, 6 and 12 months)
Patient´s satisfaction
Time Frame: Changes from baseline to after treatemnt (3, 6 and 12 months)
Measured by use of the Client Satisfaction Questionnaire (CSQ) (Bjelland 2002)
Changes from baseline to after treatemnt (3, 6 and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Region Skane
Kronoberg County Council
Blekinge County Council Hospital

Investigators

  • Principal Investigator: Birgitta EM Grahn, AssProfessor, Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS2011/005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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