RehabilitationVIMS03NCT01205542
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
A study testing Training and Reference in people with Rehabilitation and Neck Pain, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Neck Pain, Shoulder Pain
- What is being tested?
- Training and Reference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jan 2011
- 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
- employees
- more than 30 days with pain previous year
- pain intensity of at least 3 on a scale of 0-10
Who cannot join
- trauma
- life threatening disease
- pregnanacy
Trial locations and contacts
1 site in 1 country.
About this study
Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior.
We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers
- Conditions
- Rehabilitation, Neck Pain, Shoulder Pain, Scapular Dyskinesis, Muscle Activation
- Being tested
- Training, Reference
- Medical subject headings
- Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Training of scapular function with strengthening exercises using bodyweight and elastic resistance
ReferenceBehavioural
Health check and advice to continue ordinary physical activity
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Training of scapular function with strengthening exercises using bodyweight and elastic resistance Receives: Behavioral: Training |
| Reference | Active comparator | Health check and advice to continue ordinary physical activity Receives: Behavioral: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck/shoulder pain
Neck/shoulder pain will be assessed by:
- self-report (pain intensity)
- clinical examination of muscle tenderness
Measured: December 2010
Secondary outcomes (1)
Muscle function
Muscle strength and electromyography assessment
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205542
- Sponsor's protocol ID
- VIMS03
- Acronym
- VIMS03
- Status last verified
- Jan 2011
- First submitted
- 17 Sep 2010
- Last updated
- 4 Jan 2011
- Results posted
- No
Publications
Andersen CH, Andersen LL, Mortensen OS, Zebis MK, Sjogaard G. Protocol for shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial. BMC Musculoskelet Disord. 2011 Jan 14;12:14. doi: 10.1186/1471-2474-12-14.
PubMed 21235752
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. 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) - Shoulder Function
- ClinicalTrials.gov ID
- NCT01205542
- Acronym / sponsor ID
- VIMS03 / VIMS03
- Conditions
- Rehabilitation, Neck Pain, Shoulder Pain, Scapular Dyskinesis, Muscle Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Southern Denmark
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Sep 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.
Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior.
We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: TrainingTraining of scapular function with strengthening exercises using bodyweight and elastic resistance |
| Reference | Active comparator | Behavioral: ReferenceHealth check and advice to continue ordinary physical activity |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- employees
- more than 30 days with pain previous year
- pain intensity of at least 3 on a scale of 0-10
Key exclusion criteria (3 listed)
- trauma
- life threatening disease
- pregnanacy
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 |
|---|---|---|
| TrainingTraining of scapular function with strengthening exercises using bodyweight and elastic resistance | Behavioural | Training |
| ReferenceHealth check and advice to continue ordinary physical activity | Behavioural | Reference |
Primary outcome
Neck/shoulder pain
Time frame: December 2010
Neck/shoulder pain will be assessed by: 1. self-report (pain intensity) 2. clinical examination of muscle tenderness
1 secondary outcome
Muscle function
Time frame: December 2010
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 4 Jan 2011.
- Derived from this study: PubMed 21235752Andersen CH, Andersen LL, Mortensen OS, Zebis MK, Sjogaard G. Protocol for shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial. BMC Musculoskelet Disord. 2011 Jan 14;12:14. doi: 10.1186/1471-2474-12-14.
- Related InfoLink provided by the sponsor.
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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.
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 Training and Reference in people with Rehabilitation and Neck Pain, 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 3 inclusion and 3 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 4 Jan 2011. 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?
Neck/shoulder pain (time frame: December 2010). 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 NCT01205542, which also lists 1 linked publication.
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 4 Jan 2011.