Overview

This trial is active, not recruiting.

Conditions back pain, neck pain
Treatments structured care & workplace intervention, treatment as usual
Sponsor Lund University
Collaborator Region Skane
Start date January 2013
End date December 2015
Trial size 364 participants
Trial identifier NCT02609750, RS2011/005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
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)
Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee
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.

Primary Outcomes

Measure
Work ability
time frame: Changes from baseline to 3, 6, 12 months and 2 and 3 years

Secondary Outcomes

Measure
Health-related quality of life
time frame: Changes from baseline to 3, 6 and 12 months
Functional ability
time frame: Changes from baseline to 3, 6 and 12 months
Pain
time frame: Changes from baseline to 3, 6 and 12 months
Physical and psycho-social work environment
time frame: Changes from baseline to 3, 6 and 12 months
Patient´s satisfaction
time frame: Changes from baseline to 3, 6 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 67 years old.

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

Additional Information

Official title 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
Principal investigator Birgitta EM Grahn, AssProfessor
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Lund University.