Musculoskeletal DisordersIRMA10NCT02047682

Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load

A study testing Biopsychosocial and Reference in people with Musculoskeletal Disorders and Stress, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal disorders and sickness absence. Objective measurements of occupational loadings - EMG for muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate variability, actigraphy for bodily… Read more about this study

Who is it for?: Ages 18 to 67 years, women onlyHealthy volunteers can take part
Conditions the study is for: Musculoskeletal Disorders, Stress
What is being tested?: Biopsychosocial and Reference
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteDenmark
Study dates: Feb 2014to Jul 2014
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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Laboratory technician
Pain intensity >= 3 (scale of 0-10)
Pain duration >= 3 months
Pain frequency >= 3 days per week

Who cannot join

life threatening disease
pregnancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site

National Research Centre for the Working Environment
Copenhagen, 2100

Other trials in Denmark

About this study

The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on these risk factors in lab technicians with a history of work-related musculoskeletal pain.

Conditions: Musculoskeletal Disorders, Stress
Being tested: Biopsychosocial, Reference
Medical subject headings: Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiopsychosocialBehavioural
ReferenceBehavioural

Study groups in NCT02047682
Study group	Role	What they receive
Biopsychosocial	Experimental	Biopsychosocial intervention with Individually tailored physical exercises and stress management Receives: Behavioral: Biopsychosocial
Reference	Active comparator	Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises Receives: Behavioral: Reference

What is being measured

The primary outcome is the main question the study is designed to answer.

EMG gaps
Electromyography (EMG) is measured in the neck and shoulder muscles throughout a normal workday before and after the intervention. EMG gaps is defined as periods with muscular inactivity. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)
Measured: change from baseline to week 10

Secondary outcomes (2)

EEG
Electroencephalography is measured throughout a normal workday before and after the intervention. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)
Measured: change from baseline to week 10
HRV
Heart Rate Variability (HRV) is measured with Actiheart throughout the working day before and after the intervention. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)
Measured: change from baseline til 10 week followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jul 2014

First posted28 Jan 2014 (estimated)
Study startFeb 2014
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047682
Sponsor's protocol ID: IRMA10
Acronym: IRMA10
Status last verified: Sep 2014
First submitted: 26 Jan 2014
Last updated: 30 Sep 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Musculoskeletal Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load
ClinicalTrials.gov ID: NCT02047682
Acronym / sponsor ID: IRMA10 / IRMA10
Conditions: Musculoskeletal Disorders, Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: National Research Centre for the Working Environment, DenmarkOther government
Collaborators: University of Southampton
Study start: Feb 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 28 Jan 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Biopsychosocial	Experimental	Behavioral: BiopsychosocialBiopsychosocial intervention with Individually tailored physical exercises and stress management
Reference	Active comparator	Behavioral: ReferenceReference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises

Who may qualify

Ages: 18 to 67 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Laboratory technician
Pain intensity >= 3 (scale of 0-10)
Pain duration >= 3 months
Pain frequency >= 3 days per week

Key exclusion criteria (2 listed)

life threatening disease
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
Biopsychosocial	Behavioural	Biopsychosocial
Reference	Behavioural	Reference

Primary outcome

EMG gaps
Time frame: change from baseline to week 10
Electromyography (EMG) is measured in the neck and shoulder muscles throughout a normal workday before and after the intervention. EMG gaps is defined as periods with muscular inactivity. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)

2 secondary outcomes

EEG
Time frame: change from baseline to week 10
HRV
Time frame: change from baseline til 10 week followup

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 30 Sep 2014.

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Active, not recruitingPhase 1
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Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
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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 principal investigator

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 Biopsychosocial and Reference in people with Musculoskeletal Disorders and Stress, 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 4 inclusion and 2 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 30 Sep 2014. 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?

EMG gaps (time frame: change from baseline to week 10). 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 NCT02047682.

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 30 Sep 2014.