Musculoskeletal DisordersIRMANCT02047669
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
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.
Trial summary
Musculoskeletal disorders and stress of employees remain a major problem in many occupations. 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 musculoskeletal pain… 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
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 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
About this study
Musculoskeletal disorders and stress of employees remain a major problem in many occupations. 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 musculoskeletal pain, work disability, and stress 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 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.
Pain intensity
The change in "pain intensity during the last week" (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline.
Measured: change from baseline to week 10
Secondary outcomes (1)
Stress
Cohens perceived stress scale
Measured: change from baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Southern Denmark, University of Southampton
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Principal investigator, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047669
- Sponsor's protocol ID
- IRMA09
- Acronym
- IRMA
- Status last verified
- Sep 2015
- First submitted
- 26 Jan 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jay K, Brandt M, Hansen K, Sundstrup E, Jakobsen MD, Schraefel MC, Sjogaard G, Andersen LL. Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial. Pain Physician. 2015 Sep-Oct;18(5):459-71.
PubMed 26431123Jay K, Brandt M, Sundstrup E, Schraefel M, Jakobsen MD, Sjogaard G, Andersen LL. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Dec 18;15:444. doi: 10.1186/1471-2474-15-444.
PubMed 25519844
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
- ClinicalTrials.gov ID
- NCT02047669
- Acronym / sponsor ID
- IRMA / IRMA09
- Conditions
- Musculoskeletal Disorders, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Southern Denmark, University of Southampton
- Study start
- Mar 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.
Musculoskeletal disorders and stress of employees remain a major problem in many occupations. 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 musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.
Study design
- Primary purpose
- Treatment
- 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
Pain intensity
Time frame: change from baseline to week 10
The change in "pain intensity during the last week" (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline.
1 secondary outcome
Stress
Time frame: change from baseline to week 10
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 2 Sep 2015.
- Derived from this study: PubMed 26431123Jay K, Brandt M, Hansen K, Sundstrup E, Jakobsen MD, Schraefel MC, Sjogaard G, Andersen LL. Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial. Pain Physician. 2015 Sep-Oct;18(5):459-71.
- Derived from this study: PubMed 25519844Jay K, Brandt M, Sundstrup E, Schraefel M, Jakobsen MD, Sjogaard G, Andersen LL. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Dec 18;15:444. doi: 10.1186/1471-2474-15-444.
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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 2 Sep 2015. 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?
Pain intensity (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 NCT02047669, 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 2 Sep 2015.