PainNCT00801983
The Effect of Alternative Keyboards on Discomfort and Typing Kinematics
A study testing Alternative Keyboard in people with Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
Awkward postures during computer keyboard use have been hypothesized to be one cause of musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity (MSD-UE). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Alternative Keyboard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Use a computer at least 20 hrs per week
- Aged 18-65
- Experiencing some pain during computer use
Who cannot join
- Currently use an alternative keyboard
- Serious trauma injury to the upper extremity
- Rheumatic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Awkward postures during computer keyboard use have been hypothesized to be one cause of musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort and have been shown to change aspects of keyboard users' kinematics under laboratory conditions. However, research that has examined the effectiveness of alternative keyboards in reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has examined the association between postures and musculoskeletal pain. The Aims of this 3-year prospective double cross-over trial are: 1) To examine the effectiveness of an alternative keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and stability of postures during keyboard use; and 3) To identify which postures are associated with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use their assigned keyboards for 6-months before switching to the next keyboard. Every week, subjects will report their musculoskeletal pain levels. Just prior to and just after each 6-month intervention subjects' kinematics performances on the keyboards will be recorded at the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a laboratory setting using 3-dimensional motion capture technology.
Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over 6-months.
Read more
Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have significantly lower musculoskeletal pain levels than when using a standard keyboard.
Aim 2: To examine the neutrality and stability of postures during keyboard use.
Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3 (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding postures documented at baseline.
- Conditions
- Pain
- Being tested
- Alternative Keyboard
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative KeyboardDevice
Also called Microsoft Natural Ergonomic
Subjects use either a typical or alternative keyboard
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subject receives typical keyboard first for 6 months and alternative keyboard second for 6 months Receives: Device: Alternative Keyboard |
| B | Experimental | Subject receives alternative keyboard first for 6 months and typical keyboard second for 6 months Receives: Device: Alternative Keyboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal Discomfort
Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations).
We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Nancy Baker, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801983
- Sponsor's protocol ID
- 08030467
- Other IDs
- R01OH008961
- Status last verified
- Aug 2014
- First submitted
- 3 Dec 2008
- Last updated
- 22 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alternative Keyboards on Discomfort and Typing Kinematics
- ClinicalTrials.gov ID
- NCT00801983
- Acronym / sponsor ID
- 08030467
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Awkward postures during computer keyboard use have been hypothesized to be one cause of musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort and have been shown to change aspects of keyboard users' kinematics under laboratory conditions. However, research that has examined the effectiveness of alternative keyboards in reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has examined the association between postures and musculoskeletal pain. The Aims of this 3-year prospective double cross-over trial are: 1) To examine the effectiveness of an alternative keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and stability of postures during keyboard use; and 3) To identify which postures are associated with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use their assigned keyboards for 6-months before switching to the next keyboard. Every week, subjects will report their musculoskeletal pain levels. Just prior to and just after each 6-month intervention subjects' kinematics performances on the keyboards will be recorded at the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a laboratory setting using 3-dimensional motion capture technology.
Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over 6-months.
Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have significantly lower musculoskeletal pain levels than when using a standard keyboard.
Aim 2: To examine the neutrality and stability of postures during keyboard use.
Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3 (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding postures documented at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Alternative KeyboardSubject receives typical keyboard first for 6 months and alternative keyboard second for 6 months |
| B | Experimental | Device: Alternative KeyboardSubject receives alternative keyboard first for 6 months and typical keyboard second for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Use a computer at least 20 hrs per week
- Aged 18-65
- Experiencing some pain during computer use
Key exclusion criteria (3 listed)
- Currently use an alternative keyboard
- Serious trauma injury to the upper extremity
- Rheumatic disorder
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 |
|---|---|---|
| Alternative KeyboardAlso: Microsoft Natural ErgonomicSubjects use either a typical or alternative keyboard | Device | A, B |
Primary outcome
Musculoskeletal Discomfort
Time frame: 6 months and 12 months
Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations). We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Alternative Keyboard in people with Pain, run by University of Pittsburgh at 1 site in United States.
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 22 Aug 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Musculoskeletal Discomfort (time frame: 6 months and 12 months). 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 22 Aug 2014.