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

NCT02609750 | Active Not Recruiting

• 1 other identifier: RS2011/005
• Study Type: interventional
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)

Secondary Outcomes (5)

• Health-related quality of life

  Changes from baseline to after treatment (3, 6 and 12 months)

• Functional ability

  Changes from baseline to after treatment (3, 6 and 12 months)

• Pain (distribution and intensity)

  Changes from baseline to after treatment (3, 6 and 12 months)

• Physical and psycho-social work environment

  Changes from baseline to after treatment (3, 6 and 12 months)

• Patient´s satisfaction

  Changes from baseline to after treatemnt (3, 6 and 12 months)

Study Arms (2)

Structured care & workplace intervention

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).

Other: Structured care & workplace intervention

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

Structured care & workplace intervention OTHER

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.

Structured care & workplace intervention

Treatment as Usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator
• Kronoberg County Council: collaborator
• Blekinge County Council Hospital: collaborator

Related Publications (6)

• 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.

  PMID: 36104781 DERIVED

• 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.

  PMID: 32000558 DERIVED

• 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.

  PMID: 30580256 DERIVED

• 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.

  PMID: 30171489 DERIVED

• 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.

  PMID: 29554017 DERIVED

• 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.

  PMID: 28222707 DERIVED

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birgitta EM Grahn, AssProfessor

  Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03