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

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ClinicalTrials.gov Identifier: NCT02609750
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Region Skane
Kronoberg County Council
Blekinge County Council Hospital
Information provided by (Responsible Party):
Lund University

Brief 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.

Condition or disease Intervention/treatment Phase
Back Pain Neck Pain Other: Structured care & workplace intervention Other: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609750


Sponsors and Collaborators
Lund University
Region Skane
Kronoberg County Council
Blekinge County Council Hospital
Investigators
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Principal Investigator: Birgitta EM Grahn, AssProfessor Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT02609750    
Other Study ID Numbers: RS2011/005
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Back Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms