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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00801983
Other study ID # 08030467
Secondary ID R01OH008961
Status Completed
Phase N/A
First received December 3, 2008
Last updated August 6, 2014
Start date January 2009
Est. completion date August 2013

Study information

Verified date August 2014
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date August 2013
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Use a computer at least 20 hrs per week

- Aged 18-65

- Experiencing some pain during computer use

Exclusion Criteria:

- Currently use an alternative keyboard

- Serious trauma injury to the upper extremity

- Rheumatic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Alternative Keyboard
Subjects use either a typical or alternative keyboard

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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