Musculoskeletal DisordersIRMA11NCT02498197
Participatory Intervention Among Construction Workers (IRMA11)
A study testing Participatory Intervention in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Participatory Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full time construction workers who are member of a labor union and can read and understand Danish.
- The type of work must include manual work that involves lifting
Who cannot join
- life-threatening diseases
- pregnancy
- hypertension >160/100 mmHg
- unable to participate in the measurements
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
Official title: Deltagerinvolverende Intervention Mod Fysiske Risikofaktorer for Muskel- og skeletbesvær i Byggebranchen
There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Participatory ergonomic initiatives increase the success of interventions aimed at reducing physical excessive exposures.
The objectives are in two phases to; 1) determine which work-tasks in selected job-groups involve the highest load of the back and shoulders during a normal working day (using EMG, Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical workloads, drawing on information from objective measurements from phase 1.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Participatory Intervention, Control
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory InterventionBehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Participatory Intervention | Experimental | Participatory intervention with workers and their leaders. Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads Receives: Behavioral: Participatory Intervention |
| Control | Active comparator | Receive standard information about correct lifting technics, use of assistive technology, and ergonomics Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive physical load
The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load
Measured: change from baseline to 3 months follow-up
Secondary outcomes (3)
Pain intensity (0-10)
Change in "low back pain intensity during the last week" from baseline to follow-up. A horizontally oriented modified VAS scale will be used with 11 points from 0 to 10.
Measured: change from baseline to 3 months follow-up
WAI questionnaire
Work Ability Index (Ilmarinen et al)
Measured: change from baseline to 3 months follow-up
Self-efficacy Questionnaire
Self-efficacy to improve the physical work environment
Measured: change from baseline to 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Study director, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498197
- Sponsor's protocol ID
- IRMA11
- Acronym
- IRMA11
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brandt M, Madeleine P, Samani A, Ajslev JZ, Jakobsen MD, Sundstrup E, Andersen LL. Effects of a Participatory Ergonomics Intervention With Wearable Technical Measurements of Physical Workload in the Construction Industry: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Dec 19;20(12):e10272. doi: 10.2196/10272.
PubMed 30567694Brandt M, Madeleine P, Ajslev JZ, Jakobsen MD, Samani A, Sundstrup E, Kines P, Andersen LL. Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 16;16:302. doi: 10.1186/s12891-015-0758-0.
PubMed 26474867
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deltagerinvolverende Intervention Mod Fysiske Risikofaktorer for Muskel- og skeletbesvær i Byggebranchen
- ClinicalTrials.gov ID
- NCT02498197
- Acronym / sponsor ID
- IRMA11 / IRMA11
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Aalborg University
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jul 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.
There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Participatory ergonomic initiatives increase the success of interventions aimed at reducing physical excessive exposures.
The objectives are in two phases to; 1) determine which work-tasks in selected job-groups involve the highest load of the back and shoulders during a normal working day (using EMG, Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical workloads, drawing on information from objective measurements from phase 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participatory Intervention | Experimental | Behavioral: Participatory InterventionParticipatory intervention with workers and their leaders. Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads |
| Control | Active comparator | Behavioral: ControlReceive standard information about correct lifting technics, use of assistive technology, and ergonomics |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Full time construction workers who are member of a labor union and can read and understand Danish.
- The type of work must include manual work that involves lifting
Key exclusion criteria (4 listed)
- life-threatening diseases
- pregnancy
- hypertension >160/100 mmHg
- unable to participate in the measurements
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 |
|---|---|---|
| Participatory Intervention | Behavioural | Participatory Intervention |
| Control | Behavioural | Control |
Primary outcome
Excessive physical load
Time frame: change from baseline to 3 months follow-up
The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load
3 secondary outcomes
Pain intensity (0-10)
Time frame: change from baseline to 3 months follow-up
WAI questionnaire
Time frame: change from baseline to 3 months follow-up
Self-efficacy Questionnaire
Time frame: change from baseline to 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 30567694Brandt M, Madeleine P, Samani A, Ajslev JZ, Jakobsen MD, Sundstrup E, Andersen LL. Effects of a Participatory Ergonomics Intervention With Wearable Technical Measurements of Physical Workload in the Construction Industry: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Dec 19;20(12):e10272. doi: 10.2196/10272.
- Derived from this study: PubMed 26474867Brandt M, Madeleine P, Ajslev JZ, Jakobsen MD, Samani A, Sundstrup E, Kines P, Andersen LL. Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 16;16:302. doi: 10.1186/s12891-015-0758-0.
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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.
Lars L Andersen, PhD study director
National Research Centre for the Working Environment, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Intervention in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Excessive physical load (time frame: change from baseline to 3 months follow-up). 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 NCT02498197, which also lists 2 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 13 Aug 2018.