Non-specific Pain of the Neck and ShoulderVIMSNCT01071980
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers
A study testing Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck in people with Non-specific Pain of the Neck and Shoulder, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of specific resistance training on neck/shoulder pain in industrial workers. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Pain of the Neck and Shoulder
- What is being tested?
- Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Feb 2010
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- industrial worker
Who cannot join
- trauma, life threatening diseases, 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 purpose of this study is to investigate the effect of specific resistance training on neck/shoulder pain in industrial workers.
- Being tested
- Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and NeckOther
Participants will be randomized at the cluster level to a control group or 20 weeks of specific resistance training for 3 x 20 min a week
| Study group | Role | What they receive |
|---|---|---|
| Specific resistance training | Active comparator | 3 x 20 min a week of specific resistance training for 20 weeks Receives: Other: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain of the neck and shoulders
Measured: At week 0 (baseline) and week 20 (follow-up)
Pain in the arm/hand
Measured: At week 0 (baseline) and week 20 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-specific Pain of the Neck and ShoulderStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071980
- Sponsor's protocol ID
- VIMS00
- Acronym
- VIMS
- Status last verified
- Oct 2012
- First submitted
- 25 Jan 2010
- Last updated
- 11 Oct 2012
- Results posted
- No
Publications
Pedersen MT, Andersen CH, Zebis MK, Sjogaard G, Andersen LL. Implementation of specific strength training among industrial laboratory technicians: long-term effects on back, neck and upper extremity pain. BMC Musculoskelet Disord. 2013 Oct 9;14:287. doi: 10.1186/1471-2474-14-287.
PubMed 24106771Andersen CH, Andersen LL, Pedersen MT, Mortensen P, Karstad K, Mortensen OS, Zebis MK, Sjogaard G. Dose-response of strengthening exercise for treatment of severe neck pain in women. J Strength Cond Res. 2013 Dec;27(12):3322-8. doi: 10.1519/JSC.0b013e31828f12c6.
PubMed 23478473Roessler KK, Rugulies R, Bilberg R, Andersen LL, Zebis MK, Sjogaard G. Does work-site physical activity improve self-reported psychosocial workplace factors and job satisfaction? A randomized controlled intervention study. Int Arch Occup Environ Health. 2013 Nov;86(8):861-4. doi: 10.1007/s00420-012-0823-z. Epub 2012 Oct 14.
PubMed 23064844Pedersen MM, Zebis MK, Langberg H, Poulsen OM, Mortensen OS, Jensen JN, Sjogaard G, Bredahl T, Andersen LL. Influence of self-efficacy on compliance to workplace exercise. Int J Behav Med. 2013 Sep;20(3):365-70. doi: 10.1007/s12529-012-9239-0.
PubMed 22622819Andersen LL, Jakobsen MD, Pedersen MT, Mortensen OS, Sjogaard G, Zebis MK. Effect of specific resistance training on forearm pain and work disability in industrial technicians: cluster randomised controlled trial. BMJ Open. 2012 Feb 13;2(1):e000412. doi: 10.1136/bmjopen-2011-000412. Print 2012.
PubMed 22331386Zebis MK, Andersen LL, Pedersen MT, Mortensen P, Andersen CH, Pedersen MM, Boysen M, Roessler KK, Hannerz H, Mortensen OS, Sjogaard G. Implementation of neck/shoulder exercises for pain relief among industrial workers: a randomized controlled trial. BMC Musculoskelet Disord. 2011 Sep 21;12:205. doi: 10.1186/1471-2474-12-205.
PubMed 21936939
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 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) - Industrial Workers
- ClinicalTrials.gov ID
- NCT01071980
- Acronym / sponsor ID
- VIMS / VIMS00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Feb 2010 (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 purpose of this study is to investigate the effect of specific resistance training on neck/shoulder pain in industrial workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific resistance training | Active comparator | Other: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck3 x 20 min a week of specific resistance training for 20 weeks |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- industrial worker
Key exclusion criteria (1 listed)
- trauma, life threatening diseases, 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 |
|---|---|---|
| Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and NeckParticipants will be randomized at the cluster level to a control group or 20 weeks of specific resistance training for 3 x 20 min a week | Other | Specific resistance training |
Primary outcome
Pain of the neck and shoulders
Time frame: At week 0 (baseline) and week 20 (follow-up)
Pain in the arm/hand
Time frame: At week 0 (baseline) and week 20 (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 11 Oct 2012.
- Derived from this study: PubMed 24106771Pedersen MT, Andersen CH, Zebis MK, Sjogaard G, Andersen LL. Implementation of specific strength training among industrial laboratory technicians: long-term effects on back, neck and upper extremity pain. BMC Musculoskelet Disord. 2013 Oct 9;14:287. doi: 10.1186/1471-2474-14-287.
- Derived from this study: PubMed 23478473Andersen CH, Andersen LL, Pedersen MT, Mortensen P, Karstad K, Mortensen OS, Zebis MK, Sjogaard G. Dose-response of strengthening exercise for treatment of severe neck pain in women. J Strength Cond Res. 2013 Dec;27(12):3322-8. doi: 10.1519/JSC.0b013e31828f12c6.
- Derived from this study: PubMed 23064844Roessler KK, Rugulies R, Bilberg R, Andersen LL, Zebis MK, Sjogaard G. Does work-site physical activity improve self-reported psychosocial workplace factors and job satisfaction? A randomized controlled intervention study. Int Arch Occup Environ Health. 2013 Nov;86(8):861-4. doi: 10.1007/s00420-012-0823-z. Epub 2012 Oct 14.
- Derived from this study: PubMed 22622819Pedersen MM, Zebis MK, Langberg H, Poulsen OM, Mortensen OS, Jensen JN, Sjogaard G, Bredahl T, Andersen LL. Influence of self-efficacy on compliance to workplace exercise. Int J Behav Med. 2013 Sep;20(3):365-70. doi: 10.1007/s12529-012-9239-0.
- Derived from this study: PubMed 22331386Andersen LL, Jakobsen MD, Pedersen MT, Mortensen OS, Sjogaard G, Zebis MK. Effect of specific resistance training on forearm pain and work disability in industrial technicians: cluster randomised controlled trial. BMJ Open. 2012 Feb 13;2(1):e000412. doi: 10.1136/bmjopen-2011-000412. Print 2012.
- Derived from this study: PubMed 21936939Zebis MK, Andersen LL, Pedersen MT, Mortensen P, Andersen CH, Pedersen MM, Boysen M, Roessler KK, Hannerz H, Mortensen OS, Sjogaard G. Implementation of neck/shoulder exercises for pain relief among industrial workers: a randomized controlled trial. BMC Musculoskelet Disord. 2011 Sep 21;12:205. doi: 10.1186/1471-2474-12-205.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck in people with Non-specific Pain of the Neck and Shoulder, 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 1 inclusion and 1 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 Oct 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.
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 of the neck and shoulders (time frame: At week 0 (baseline) and week 20 (follow-up)). The study lists 2 primary outcomes in all. 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 NCT01071980, which also lists 6 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 Oct 2012.