Musculoskeletal DisordersIRMANCT01671267
Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
A study testing Strength training and Ergonomic in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the substantial load of these body regions during work. Work disability is a common consequence of these pains. 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?
- Strength training and Ergonomic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Feb 2013
- 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
- Slaughterhouse worker
- the pain should have lasted at least 3 months
- pain intensity during the last three months of >= 3 (scale 0-10) in the shoulder, elbow or hand
- the pain should be frequent (at least 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
The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the substantial load of these body regions during work. Work disability is a common consequence of these pains. Lowering the physical exposure through ergonomic intervention may be a strategy to reduce the workload. An alternative strategy could be to increase the physical capacity through strength training of the shoulder-, arm- and hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load reduction (ergonomic intervention) versus training of physical capacity (strength training) on pain and work disability in slaughterhouse workers.
The main hypothesis is that strength training intervention for 10 weeks compared with ergonomic intervention results in reduced pain of the shoulder, arm and hand.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Strength training, Ergonomic
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
ErgonomicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week. Receives: Behavioral: Strength training |
| Ergonomic | Active comparator | Receives counseling on workstation adjustment and optimal use of the work tools. Receives: Behavioral: Ergonomic |
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 shoulder, elbow and hand) from baseline to 10 week follow-up between the strength training group and ergonomic group. The ergonomic group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor.
Measured: change from baseline to week 10
Secondary outcomes (1)
DASH
Disability of the arm, shoulder and hand questionnaire (DASH). Only the work-module of DASH will be included. Analyzed the same way as the primary outcome.
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 posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- 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
- NCT01671267
- Sponsor's protocol ID
- IRMA06
- Acronym
- IRMA
- Status last verified
- Jan 2014
- First submitted
- 20 Aug 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sundstrup E, Jakobsen MD, Brandt M, Jay K, Aagaard P, Andersen LL. Strength Training Improves Fatigue Resistance and Self-Rated Health in Workers with Chronic Pain: A Randomized Controlled Trial. Biomed Res Int. 2016;2016:4137918. doi: 10.1155/2016/4137918. Epub 2016 Oct 17.
PubMed 27830144Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial. Pain Physician. 2014 Mar-Apr;17(2):145-54.
PubMed 24658475Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Participatory ergonomic intervention versus strength training on chronic pain and work disability in slaughterhouse workers: study protocol for a single-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Feb 21;14:67. doi: 10.1186/1471-2474-14-67.
PubMed 23433448
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
- ClinicalTrials.gov ID
- NCT01671267
- Acronym / sponsor ID
- IRMA / IRMA06
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Aug 2012 (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.
The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the substantial load of these body regions during work. Work disability is a common consequence of these pains. Lowering the physical exposure through ergonomic intervention may be a strategy to reduce the workload. An alternative strategy could be to increase the physical capacity through strength training of the shoulder-, arm- and hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load reduction (ergonomic intervention) versus training of physical capacity (strength training) on pain and work disability in slaughterhouse workers.
The main hypothesis is that strength training intervention for 10 weeks compared with ergonomic intervention results in reduced pain of the shoulder, arm and hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Behavioral: Strength trainingStrength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week. |
| Ergonomic | Active comparator | Behavioral: ErgonomicReceives counseling on workstation adjustment and optimal use of the work tools. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Slaughterhouse worker
- the pain should have lasted at least 3 months
- pain intensity during the last three months of >= 3 (scale 0-10) in the shoulder, elbow or hand
- the pain should be frequent (at least 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 |
|---|---|---|
| Strength training | Behavioural | Strength training |
| Ergonomic | Behavioural | Ergonomic |
Primary outcome
Pain intensity
Time frame: change from baseline to week 10
The change in "pain intensity during the last week" (average value of shoulder, elbow and hand) from baseline to 10 week follow-up between the strength training group and ergonomic group. The ergonomic group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor.
1 secondary outcome
DASH
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 28 Jan 2014.
- Derived from this study: PubMed 27830144Sundstrup E, Jakobsen MD, Brandt M, Jay K, Aagaard P, Andersen LL. Strength Training Improves Fatigue Resistance and Self-Rated Health in Workers with Chronic Pain: A Randomized Controlled Trial. Biomed Res Int. 2016;2016:4137918. doi: 10.1155/2016/4137918. Epub 2016 Oct 17.
- Derived from this study: PubMed 24658475Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial. Pain Physician. 2014 Mar-Apr;17(2):145-54.
- Derived from this study: PubMed 23433448Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Participatory ergonomic intervention versus strength training on chronic pain and work disability in slaughterhouse workers: study protocol for a single-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Feb 21;14:67. doi: 10.1186/1471-2474-14-67.
Related trials for Musculoskeletal Disorders
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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 Strength training and Ergonomic 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 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 28 Jan 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?
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 NCT01671267, which also lists 3 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 28 Jan 2014.