- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656953
The Impact of Lenses on Musculoskeletal and Visual Complaints in VDU Workers With Neck Complaints
The Impact of Wearing VDU Lenses Versus Progressive Lenses on Musculoskeletal and Visual Complaints in VDU Workers With Work Related Neck Complaints: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of visual display units (VDU) is often accompanied by physical complaints of the neck, shoulder, forearm and hand, especially in people who make extensive use of computers at work. Besides this, VDU operators also experience eye discomfort and vision problems when working with the computer for a long period.
With the increase of computer use, VDU glasses were developed. They provide a clear vision of the intermediate zone at a distance of approximately 70 centimeters, which is closer than distant vision at a distance of more than 2 meters (e.g. driving), but further than near vision at a distance of 40 centimeters (e.g. reading), so the computer screen is seen clear without the need for excessive focusing effort or bad postures. Progressive lenses have some lens power for this intermediate zone as well, but this zone might not be large enough for comfortable and ergonomic computer work. VDU glasses are often progressive glasses as well, so they can be used to read and see things beyond the computer screen clear during computer work.
The research question of this study is "What is the impact of wearing progressive VDU lenses versus progressive lenses, for six months, on both musculoskeletal and visual complaints in VDU workers with work related neck complaints ?"
To find an answer to this question, 40 VDU workers (men and women) with work related neck/shoulder complaints, were recruited from a bank office where they perform predominantly VDU work. All participants will receive information and have to sign an informed consent form.
A questionnaire concerning visual and musculoskeletal complaints, in which the Neck Disability Index (NDI) Questionnaire had to be completed at the beginning of the experiment. Participants were tested with their old glasses in a landscape office while performing a 20 minute VDU task. Before and after the task, viscoelastic properties (MyotonPRO®) of the trapezius muscle and the PPT (WagnerTM FDX 50 hand-held pressure algometer) of the trapezius muscle, the levator scapulae muscle and the infraspinatus muscle were measured. A 2D video analysis was performed during the task.The Forward Head Angle (FHA) and the Forward Shoulder Angle (FSA) was measured afterwards. After this, participants were asked to fill out a short questionnaire, in which the Visual Fatigue Questionnaire was included, every two weeks during two months. On the 15th of June, 2015 the participants received new glasses and were asked to wear these for six months during computer work. During this period the same short questionnaire had to be filled out every two weeks. The test procedure will be repeated with the new glasses after six months of wearing these. A shorter version of the first questionnaire will be completed at the end of the experiment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Minimum 4 hours a day and 20 hours a week of VDU work
- Work related neck/shoulder complaints
- Difference in spectacle correction for presbyopia and myopia of minimum 1.5 dioptres
Exclusion Criteria:
- Active eye disease that can't be corrected with eyeglasses
- Drugs that strongly influence eye or muscle function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VDU lenses
VDU lenses provide a clear vision of the intermediate zone at a distance of approximately 70 centimeters, which is closer than distant vision at a distance of more than 2 meters (e.g.
driving), but further than near vision at a distance of 40 centimeters (e.g.
reading), so the computer screen is seen clear without the need for excessive focusing effort or bad postures.
In this study Zeiss® Officelens Plus lenses with a Silhouette® frame were used.
|
The treatment group (n=22) was given progressive VDU glasses (Zeiss® Officelens Plus), specially designed for VDU work.
The participants were asked to wear their new glasses for six months during computer work.
|
|
Active Comparator: Progressive lenses
Progressive lenses or multifocal lenses provide a continuous range of focal power between near and far distances.Progressive lenses have some lens power for the intermediate zone as well, but this zone might not be large enough for comfortable and ergonomic computer work.
In this study Zeiss® Multifocal Precision Plus lenses with a Silhouette® frame were used.
|
The comparison group (n=18) was given progressive glasses (Zeiss® Multifocal Precision Plus).
The participants were asked to wear their new glasses for six months during computer work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in functionality using the Neck disability index (NDI)
Time Frame: At baseline and six months
|
The NDI consists of ten questions concerning pain and daily living activities such as lifting, reading, driving, etc. and the maximum score is 50.
|
At baseline and six months
|
|
Change in visual complaints using the Visual Fatigue Questionnaire
Time Frame: At baseline and six months
|
The questionnaire consists of 15 questions which have to be answered on a visual analogue scale ranging from zero to ten.
It enquires eye strain, impaired vision, impaired eye surface and problems of the outside of the eyes, headache for example.
The maximum score is 10.
|
At baseline and six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle elasticity by using the MyotonPRO® device
Time Frame: At baseline and six months
|
The MyotonPRO® is a digital device that measures the elasticity (logarithmic decrement) of a muscle.
|
At baseline and six months
|
|
Change in muscle stiffness by using the MyotonPRO® device
Time Frame: At baseline and six months
|
The MyotonPRO® is a digital device that measures muscle stiffness, this is expressed in N/m.
|
At baseline and six months
|
|
Change in muscle tone by using the MyotonPRO® device
Time Frame: At baseline and six months
|
The MyotonPRO® is a digital device that measures muscle tone, this is expressed in Hz
|
At baseline and six months
|
|
Change in pressure pain threshold by using the WagnerTM FDX 50 hand-held pressure algometer
Time Frame: At baseline and six months
|
The WagnerTM FDX 50 hand-held pressure algometer is a digital device that measures the point at which pressure (N) becomes unpleasant, also known as the pressure pain threshold (PPT).
|
At baseline and six months
|
|
Change in head posture during a VDU task by means of 2D video analysis
Time Frame: At baseline and six months
|
A 2D video analysis of the head posture was performed during a VDU task using a Logitech® webcam with a Zeiss® Tessar HD 1080p lens and MaxTRAQ and MaxMATE software.
|
At baseline and six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Cagnie, PhD, University Ghent
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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