Musculoskeletal DisordersEarly Phase 1VIMSNCT01027390
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
A Early Phase 1 study testing physical training exercise in people with Musculoskeletal Disorders, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder area. The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain. The two sub-hypotheses are 1. Alleviation of pain is independent of training frequency 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- physical training exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Feb 2011
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- office workers
- employed
Who cannot join
- physically heavy work
- trauma
- leif threatening disease, e.g. cancer,
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS, Danish Acronym)
Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder area.
The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain.
The two sub-hypotheses are
- Alleviation of pain is independent of training frequency
- Alleviation of pain is higher following supervised training vs training with initial instruction only
Read the detailed description
Recent studies have shown a positive effect of work site physical exercise intervention, however, there is a lack of evidence regarding: 1) extend of instruction and supervision, and 2) frequency of training session during the wek.
Questionnaires will be send to around 2000 office workers inviting them to participate in work site training for 1 hr per week for 20 weeks. Those accepting the invitation will be randomized into 5 different groups:
- training 1 hr one time per week supervized 50% of the time
- training 3 x 20 min per week supervised 50 % of the time
- training 3 x 20 min per week supervised only initially with careful instructions
- training 10 x 6 min per week supervised 50 % of the time
- no training serving as reference control group At termination of the training period there will be a follow-up questionnaire survey
- Conditions
- Musculoskeletal Disorders
- Being tested
- physical training exercise
- Keywords
- neck/shoulder
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical training exerciseBehavioural
physical exercise training at the work site during work time
| Study group | Role | What they receive |
|---|---|---|
| 1 hr training 50% supervision | Experimental | 1 hr training 50% supervision Receives: Behavioral: physical training exercise |
| 3 x 20 min training 50% supervision | Experimental | 3 x 20 min training 50% supervision Receives: Behavioral: physical training exercise |
| 3 x 20 min training initial instructions | Experimental | 3 x 20 min training initial instructions Receives: Behavioral: physical training exercise |
| 10 x 6 min training 50% supervision | Experimental | 10 x 6 min training 50% supervision Receives: Behavioral: physical training exercise |
| reference | No intervention | no training |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck/shoulder pain, selfreported
Measured: 20 weeks
Secondary outcomes (1)
muscle strength and endurance
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionFeb 2011
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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, University of Copenhagen
- Responsible party
- Principal investigator, Gisela Sjogaard, University of Southern Denmark
- Investigators
- Gisela Sjogaard, Dr.Med.Sci., Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027390
- Sponsor's protocol ID
- H-C-2008-103
- Acronym
- VIMS
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen CH, Andersen LL, Gram B, Pedersen MT, Mortensen OS, Zebis MK, Sjogaard G. Influence of frequency and duration of strength training for effective management of neck and shoulder pain: a randomised controlled trial. Br J Sports Med. 2012 Nov;46(14):1004-10. doi: 10.1136/bjsports-2011-090813. Epub 2012 Jun 29.
PubMed 22753863Andersen LL, Zebis MK, Pedersen MT, Roessler KK, Andersen CH, Pedersen MM, Feveile H, Mortensen OS, Sjogaard G. Protocol for work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (VIMS): a cluster randomized controlled trial. BMC Musculoskelet Disord. 2010 Aug 5;11:173. doi: 10.1186/1471-2474-11-173.
PubMed 20687940Dalager T, Bredahl TG, Pedersen MT, Boyle E, Andersen LL, Sjogaard G. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial. Man Ther. 2015 Oct;20(5):657-65. doi: 10.1016/j.math.2015.01.016. Epub 2015 Feb 28.
PubMed 25816746
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS, Danish Acronym)
- ClinicalTrials.gov ID
- NCT01027390
- Acronym / sponsor ID
- VIMS / H-C-2008-103
- Conditions
- Musculoskeletal Disorders
- Keywords
- neck/shoulder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, University of Copenhagen
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Dec 2009 (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 are frequent among office workers especially in the neck/shoulder area.
The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain.
The two sub-hypotheses are
- Alleviation of pain is independent of training frequency
- Alleviation of pain is higher following supervised training vs training with initial instruction only
Detailed description
Recent studies have shown a positive effect of work site physical exercise intervention, however, there is a lack of evidence regarding: 1) extend of instruction and supervision, and 2) frequency of training session during the wek.
Questionnaires will be send to around 2000 office workers inviting them to participate in work site training for 1 hr per week for 20 weeks. Those accepting the invitation will be randomized into 5 different groups:
- training 1 hr one time per week supervized 50% of the time
- training 3 x 20 min per week supervised 50 % of the time
- training 3 x 20 min per week supervised only initially with careful instructions
- training 10 x 6 min per week supervised 50 % of the time
- no training serving as reference control group At termination of the training period there will be a follow-up questionnaire survey
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 hr training 50% supervision | Experimental | Behavioral: physical training exercise1 hr training 50% supervision |
| 3 x 20 min training 50% supervision | Experimental | Behavioral: physical training exercise3 x 20 min training 50% supervision |
| 3 x 20 min training initial instructions | Experimental | Behavioral: physical training exercise3 x 20 min training initial instructions |
| 10 x 6 min training 50% supervision | Experimental | Behavioral: physical training exercise10 x 6 min training 50% supervision |
| reference | No intervention | –no training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- office workers
- employed
Key exclusion criteria (4 listed)
- physically heavy work
- trauma
- leif threatening disease, e.g. cancer,
- 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 |
|---|---|---|
| physical training exercisephysical exercise training at the work site during work time | Behavioural | 1 hr training 50% supervision, 10 x 6 min training 50% supervision, 3 x 20 min training 50% supervision, 3 x 20 min training initial instructions |
Primary outcome
neck/shoulder pain, selfreported
Time frame: 20 weeks
1 secondary outcome
muscle strength and endurance
Time frame: 20 weeks
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 11 Dec 2012.
- Results publication: PubMed 22753863Andersen CH, Andersen LL, Gram B, Pedersen MT, Mortensen OS, Zebis MK, Sjogaard G. Influence of frequency and duration of strength training for effective management of neck and shoulder pain: a randomised controlled trial. Br J Sports Med. 2012 Nov;46(14):1004-10. doi: 10.1136/bjsports-2011-090813. Epub 2012 Jun 29.
- Results publication: PubMed 20687940Andersen LL, Zebis MK, Pedersen MT, Roessler KK, Andersen CH, Pedersen MM, Feveile H, Mortensen OS, Sjogaard G. Protocol for work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (VIMS): a cluster randomized controlled trial. BMC Musculoskelet Disord. 2010 Aug 5;11:173. doi: 10.1186/1471-2474-11-173.
- Derived from this study: PubMed 25816746Dalager T, Bredahl TG, Pedersen MT, Boyle E, Andersen LL, Sjogaard G. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial. Man Ther. 2015 Oct;20(5):657-65. doi: 10.1016/j.math.2015.01.016. Epub 2015 Feb 28.
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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.
Gisela Sjogaard, Dr.Med.Sci. principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing physical training exercise in people with Musculoskeletal Disorders, run by University of Southern 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 11 Dec 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
neck/shoulder pain, selfreported (time frame: 20 weeks). 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 NCT01027390, 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 11 Dec 2012.