Symptomatic Musculoskeletal DiseasesPhase 1I-PreventiveNCT02350244
Active Prevention of MSDs (Musculoskeletal Disorders, Upper and Spine Members) in the Context of Computer Screen Work
A Phase 1 study testing Computer program in people with Symptomatic Musculoskeletal Diseases and Latent Musculoskeletal Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Musculoskeletal Diseases, Latent Musculoskeletal Diseases
- What is being tested?
- Computer program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Jan 2015
- Phase
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - To carry out a professional activity.
- To be involved in a computer work for at least 5 hours a day.
- To be between 18 and 65 years.
Who cannot join
- - To be in sick leave.
- Rheumatic and neurological diseases which needed treatment.
- Workstations which have been recently changed.
- A behavioral and/or comprehension trouble
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment.
Read the detailed description
The benefit of the intervention will be assessed among four groups of subjects: symptomatic and asymptomatic subjects randomized in control or experimental group.
Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work. Control group patients had no intervention.
Symptoms of MSD will be assessed via questionnaire before and after intervention, in all groups.
- Being tested
- Computer program
- Keywords
- musculoskeletal diseases, eyestrain, occupational diseases, computer work, muscle stretching exercise, computer software application, MSDs
- Medical subject headings
- Musculoskeletal Diseases, Asthenopia, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer programBehavioural
Intervention consists in a computer program suggesting workers to take active breaks at given times of their working day, during one month.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work Receives: Behavioral: Computer program |
| Control group | Other | Control group patients had no intervention Receives: Behavioral: Computer program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nordic style questionnaire score
Measured: at 1 month
Secondary outcomes (5)
Evolution of " Nordic style " and eyestrain questionnaires
Measured: at 1 month
Evolution of global psychological status (HAD)
Measured: at 1 month
Evolution of psychosocial work characteristics (VAS stress and satisfaction at work)
Measured: at 1 month
Occurrence sick leave and frequency of work trips during the study.
Measured: at 1 month
Adherence to the self-program
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionJan 2015
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 Symptomatic Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350244
- Sponsor's protocol ID
- CHU-0219
- Acronym
- I-Preventive
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
Publications
Lanhers C, Pereira B, Garde G, Maublant C, Dutheil F, Coudeyre E. Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial. BMJ Open. 2016 Sep 22;6(9):e011304. doi: 10.1136/bmjopen-2016-011304.
PubMed 27660316
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Prevention of MSDs (Musculoskeletal Disorders, Upper and Spine Members) in the Context of Computer Screen Work
- ClinicalTrials.gov ID
- NCT02350244
- Acronym / sponsor ID
- I-Preventive / CHU-0219
- Keywords
- musculoskeletal diseases, eyestrain, occupational diseases, computer work, muscle stretching exercise, computer software application, MSDs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Jan 2015 (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.
Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment.
Detailed description
The benefit of the intervention will be assessed among four groups of subjects: symptomatic and asymptomatic subjects randomized in control or experimental group.
Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work. Control group patients had no intervention.
Symptoms of MSD will be assessed via questionnaire before and after intervention, in all groups.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Computer programSubjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work |
| Control group | Other | Behavioral: Computer programControl group patients had no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - To carry out a professional activity.
- To be involved in a computer work for at least 5 hours a day.
- To be between 18 and 65 years.
Key exclusion criteria (4 listed)
- - To be in sick leave.
- Rheumatic and neurological diseases which needed treatment.
- Workstations which have been recently changed.
- A behavioral and/or comprehension trouble
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 |
|---|---|---|
| Computer programIntervention consists in a computer program suggesting workers to take active breaks at given times of their working day, during one month. | Behavioural | Control group, Experimental group |
Primary outcome
Nordic style questionnaire score
Time frame: at 1 month
5 secondary outcomes
Evolution of " Nordic style " and eyestrain questionnaires
Time frame: at 1 month
Evolution of global psychological status (HAD)
Time frame: at 1 month
Evolution of psychosocial work characteristics (VAS stress and satisfaction at work)
Time frame: at 1 month
Occurrence sick leave and frequency of work trips during the study.
Time frame: at 1 month
Adherence to the self-program
Time frame: at 1 month
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 29 Jan 2015.
- Derived from this study: PubMed 27660316Lanhers C, Pereira B, Garde G, Maublant C, Dutheil F, Coudeyre E. Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial. BMJ Open. 2016 Sep 22;6(9):e011304. doi: 10.1136/bmjopen-2016-011304.
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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 Phase 1 study testing Computer program in people with Symptomatic Musculoskeletal Diseases and Latent Musculoskeletal Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 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 29 Jan 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 France. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Nordic style questionnaire score (time frame: at 1 month). 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 NCT02350244, 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 29 Jan 2015.