Back PainWorkUpNCT02609750
WorkUp. Structured Care With Workplace Interventions to Improve Work Ability in Patients With Neck and/or Low Back Pain
A study testing Structured care & workplace intervention and Treatment as Usual in people with Back Pain and Neck Pain, run by Lund University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- What is being tested?
- Structured care & workplace intervention and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- identified abuse
- retirement pension
- ongoing acute medical treatment
- pregnancy
About this study
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
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.
Read the 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.
- Being tested
- Structured care & workplace intervention, Treatment as Usual
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured care & workplace interventionOther
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.
Treatment as UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Structured care & workplace intervention |
| Treatment as Usual | Active comparator | Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)
Secondary outcomes (5)
Health-related quality of life
Measured by EQ-5D (Euroqol 2011 EQ-5D)
Measured: Changes from baseline to after treatment (3, 6 and 12 months)
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)
Measured: Changes from baseline to after treatment (3, 6 and 12 months)
Pain (distribution and intensity)
Measured by the Pain mannequin (Bergman et al 2001) and VAS (Sieper et al 2009)
Measured: Changes from baseline to after treatment (3, 6 and 12 months)
Physical and psycho-social work environment
Measured by questions focusing on known risk factors according to Lindell´s thesis (2010) and the ULF questionnaire
Measured: Changes from baseline to after treatment (3, 6 and 12 months)
Patient´s satisfaction
Measured by use of the Client Satisfaction Questionnaire (CSQ) (Bjelland 2002)
Measured: Changes from baseline to after treatemnt (3, 6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Kronoberg County Council, Blekinge County Council Hospital
- Responsible party
- Sponsor
- Investigators
- Birgitta EM Grahn, AssProfessor, Principal investigator, Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609750
- Sponsor's protocol ID
- RS2011/005
- Acronym
- WorkUp
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2015
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36104781Forsbrand 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.
PubMed 32000558Forsbrand 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.
PubMed 30580256Saha 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.
PubMed 30171489Sennehed 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.
PubMed 29554017Forsbrand 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.
PubMed 28222707
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02609750
- Acronym / sponsor ID
- WorkUp / RS2011/005
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane, Kronoberg County Council, Blekinge County Council Hospital
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured care & workplace intervention | Experimental | Other: Structured care & workplace interventionThrough 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). |
| Treatment as Usual | Active comparator | Other: Treatment as UsualPatients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- identified abuse
- retirement pension
- ongoing acute medical treatment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured care & workplace interventionIn 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. | Other | Structured care & workplace intervention |
| Treatment as UsualPatients 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. | Other | Treatment as Usual |
Primary outcome
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
5 secondary outcomes
Health-related quality of life
Time frame: 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)
Pain (distribution and intensity)
Time frame: 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)
Patient´s satisfaction
Time frame: Changes from baseline to after treatemnt (3, 6 and 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 36104781Axen 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.
- Derived from this study: PubMed 32000558Forsbrand 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.
- Derived from this study: PubMed 30580256Forsbrand 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.
- Derived from this study: PubMed 30171489Saha 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.
- Derived from this study: PubMed 29554017Sennehed 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.
- Derived from this study: PubMed 28222707Forsbrand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitta EM Grahn, AssProfessor principal investigator
Dep of Clinical Sciences Lund, Orthopedics, Lund University, and FoU Kronoberg, Region Kronoberg
Questions about this trial
What is this clinical trial studying?
A study testing Structured care & workplace intervention and Treatment as Usual in people with Back Pain and Neck Pain, run by Lund University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work ability (time frame: Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609750, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.