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Neck PainNCT02656953

The Impact of Lenses on Musculoskeletal and Visual Complaints in VDU Workers With Neck Complaints

A study testing VDU lenses (Zeiss® Officelens Plus) and Progressive lenses (Zeiss® Multifocal Precision Plus) in people with Neck Pain, run by University Ghent.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate the impact of wearing visual display units (VDU) lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers with work related neck complaints. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Neck Pain
What is being tested?
VDU lenses (Zeiss® Officelens Plus) and Progressive lenses (Zeiss® Multifocal Precision Plus)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Mar 2015to May 2016
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 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Active eye disease that can't be corrected with eyeglasses
  • Drugs that strongly influence eye or muscle function

About this study

Official title: 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

The aim of this study is to investigate the impact of wearing visual display units (VDU) lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers with work related neck complaints. This will be evaluated by means of questionnaires (Neck Disability Index and Visual Fatigue Questionnaire), muscle tone, elasticity and stiffness, pressure pain threshold and 2D video analysis of head posture during a VDU task.

Read the 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.

Conditions
Neck Pain
Being tested
VDU lenses (Zeiss® Officelens Plus), Progressive lenses (Zeiss® Multifocal Precision Plus)
Keywords
VDU workers, VDU lenses, Neck complaints, Visual complaints
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VDU lenses (Zeiss® Officelens Plus)Other

    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.

  • Progressive lenses (Zeiss® Multifocal Precision Plus)Other

    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.

Study groups in NCT02656953
Study groupRoleWhat they receive
VDU lensesExperimentalVDU 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.
Receives: Other: VDU lenses (Zeiss® Officelens Plus)
Progressive lensesActive comparatorProgressive 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.
Receives: Other: Progressive lenses (Zeiss® Multifocal Precision Plus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in functionality using the Neck disability index (NDI)

    The NDI consists of ten questions concerning pain and daily living activities such as lifting, reading, driving, etc. and the maximum score is 50.

    Measured: At baseline and six months

  2. Change in visual complaints using the Visual Fatigue Questionnaire

    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.

    Measured: At baseline and six months

Secondary outcomes (5)
  1. Change in muscle elasticity by using the MyotonPRO® device

    The MyotonPRO® is a digital device that measures the elasticity (logarithmic decrement) of a muscle.

    Measured: At baseline and six months

  2. Change in muscle stiffness by using the MyotonPRO® device

    The MyotonPRO® is a digital device that measures muscle stiffness, this is expressed in N/m.

    Measured: At baseline and six months

  3. Change in muscle tone by using the MyotonPRO® device

    The MyotonPRO® is a digital device that measures muscle tone, this is expressed in Hz

    Measured: At baseline and six months

  4. Change in pressure pain threshold by using the WagnerTM FDX 50 hand-held pressure algometer

    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).

    Measured: At baseline and six months

  5. Change in head posture during a VDU task by means of 2D video analysis

    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.

    Measured: At baseline and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2015
  4. Study completionMay 2016

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656953
Sponsor's protocol ID
20150115
Status last verified
Dec 2022
First submitted
18 Dec 2015
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VDU lenses (Zeiss® Officelens Plus) and Progressive lenses (Zeiss® Multifocal Precision Plus) in people with Neck Pain, run by University Ghent.

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 2 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in functionality using the Neck disability index (NDI) (time frame: At baseline and six months). 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?
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 8 Dec 2022.

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