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

Primary Purpose

Back Pain, Neck Pain

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured care & workplace intervention
Treatment as Usual
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Structured care & workplace intervention

    Treatment as Usual

    Arm Description

    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).

    Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee

    Outcomes

    Primary Outcome Measures

    Work ability
    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

    Health-related quality of life
    Measured by EQ-5D (Euroqol 2011 EQ-5D)
    Functional ability
    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)
    Pain (distribution and intensity)
    Measured by the Pain mannequin (Bergman et al 2001) and VAS (Sieper et al 2009)
    Physical and psycho-social work environment
    Measured by questions focusing on known risk factors according to Lindell´s thesis (2010) and the ULF questionnaire
    Patient´s satisfaction
    Measured by use of the Client Satisfaction Questionnaire (CSQ) (Bjelland 2002)

    Full Information

    First Posted
    November 18, 2015
    Last Updated
    April 12, 2022
    Sponsor
    Lund University
    Collaborators
    Region Skane, Kronoberg County Council, Blekinge County Council Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02609750
    Brief Title
    WorkUp. Structured Care With Workplace Interventions to Improve Work Ability in Patients With Neck and/or Low Back Pain
    Acronym
    WorkUp
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lund University
    Collaborators
    Region Skane, Kronoberg County Council, Blekinge County Council Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain, Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    364 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Structured care & workplace intervention
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee
    Intervention Type
    Other
    Intervention Name(s)
    Structured care & workplace intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Treatment as Usual
    Intervention Description
    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 Measure Information:
    Title
    Work ability
    Description
    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
    Time Frame
    Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)
    Secondary Outcome Measure Information:
    Title
    Health-related quality of life
    Description
    Measured by EQ-5D (Euroqol 2011 EQ-5D)
    Time Frame
    Changes from baseline to after treatment (3, 6 and 12 months)
    Title
    Functional ability
    Description
    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)
    Time Frame
    Changes from baseline to after treatment (3, 6 and 12 months)
    Title
    Pain (distribution and intensity)
    Description
    Measured by the Pain mannequin (Bergman et al 2001) and VAS (Sieper et al 2009)
    Time Frame
    Changes from baseline to after treatment (3, 6 and 12 months)
    Title
    Physical and psycho-social work environment
    Description
    Measured by questions focusing on known risk factors according to Lindell´s thesis (2010) and the ULF questionnaire
    Time Frame
    Changes from baseline to after treatment (3, 6 and 12 months)
    Title
    Patient´s satisfaction
    Description
    Measured by use of the Client Satisfaction Questionnaire (CSQ) (Bjelland 2002)
    Time Frame
    Changes from baseline to after treatemnt (3, 6 and 12 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Birgitta EM Grahn, AssProfessor
    Organizational Affiliation
    Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36104781
    Citation
    Axen I, Sennehed CP, Eek F, Stigmar K. Can a workplace dialogue impact the perceived influence of neck and/or backpain on everyday activities and performance at work? A secondary analysis from the randomized controlled trial WorkUp. BMC Musculoskelet Disord. 2022 Sep 15;23(1):861. doi: 10.1186/s12891-022-05812-w.
    Results Reference
    derived
    PubMed Identifier
    32000558
    Citation
    Forsbrand MH, Turkiewicz A, Petersson IF, Sennehed CP, Stigmar K. Long-term effects on function, health-related quality of life and work ability after structured physiotherapy including a workplace intervention. A secondary analysis of a randomised controlled trial (WorkUp) in primary care for patients with neck and/or back pain. Scand J Prim Health Care. 2020 Mar;38(1):92-100. doi: 10.1080/02813432.2020.1717081. Epub 2020 Jan 30.
    Results Reference
    derived
    PubMed Identifier
    30580256
    Citation
    Forsbrand MH, Grahn B, Hill JC, Petersson IF, Post Sennehed C, Stigmar K. Can the STarT Back Tool predict health-related quality of life and work ability after an acute/subacute episode with back or neck pain? A psychometric validation study in primary care. BMJ Open. 2018 Dec 22;8(12):e021748. doi: 10.1136/bmjopen-2018-021748.
    Results Reference
    derived
    PubMed Identifier
    30171489
    Citation
    Saha S, Grahn B, Gerdtham UG, Stigmar K, Holmberg S, Jarl J. Structured physiotherapy including a work place intervention for patients with neck and/or back pain in primary care: an economic evaluation. Eur J Health Econ. 2019 Mar;20(2):317-327. doi: 10.1007/s10198-018-1003-1. Epub 2018 Aug 31.
    Results Reference
    derived
    PubMed Identifier
    29554017
    Citation
    Sennehed CP, Holmberg S, Axen I, Stigmar K, Forsbrand M, Petersson IF, Grahn B. Early workplace dialogue in physiotherapy practice improved work ability at 1-year follow-up-WorkUp, a randomised controlled trial in primary care. Pain. 2018 Aug;159(8):1456-1464. doi: 10.1097/j.pain.0000000000001216.
    Results Reference
    derived
    PubMed Identifier
    28222707
    Citation
    Forsbrand M, Grahn B, Hill JC, Petersson IF, Sennehed CP, Stigmar K. Comparison of the Swedish STarT Back Screening Tool and the Short Form of the Orebro Musculoskeletal Pain Screening Questionnaire in patients with acute or subacute back and neck pain. BMC Musculoskelet Disord. 2017 Feb 21;18(1):89. doi: 10.1186/s12891-017-1449-9.
    Results Reference
    derived

    Learn more about this trial

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

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