NCT00801983

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 22, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

December 3, 2008

Results QC Date

May 19, 2014

Last Update Submit

August 6, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months and 12 months

Study Arms (2)

A

EXPERIMENTAL

Subject receives typical keyboard first for 6 months and alternative keyboard second for 6 months

Device: Alternative Keyboard

B

EXPERIMENTAL

Subject receives alternative keyboard first for 6 months and typical keyboard second for 6 months

Device: Alternative Keyboard

Interventions

Subjects use either a typical or alternative keyboard

Also known as: Microsoft Natural Ergonomic
AB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Use a computer at least 20 hrs per week
  • Aged 18-65
  • Experiencing some pain during computer use

You may not qualify if:

  • Currently use an alternative keyboard
  • Serious trauma injury to the upper extremity
  • Rheumatic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Nancy Baker
Organization
University of Pittsburgh

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

January 1, 2009

Primary Completion

April 1, 2011

Study Completion

August 1, 2013

Last Updated

August 22, 2014

Results First Posted

August 22, 2014

Record last verified: 2014-08

Locations