Study Protocol for CTS and Keyboard Controlled Randomized Trial
Completed · Not applicable
Conditions studied: Carpal Tunnel Syndrome
In brief
The study hypothesis is that there is a relationship between the keyboard layout and carpal tunnel syndrome (CTS). Specifically, use of the standard QWERTY keyboard increases the risk of symptoms of carpal tunnel syndrome. The QWERTY keyboard requires more effort by the fingers than necessary to perform the required work, i.e. data or word entry; up to 200 percent more flexion and extension and 100 percent more distance traveled. The purpose of the protocol is to evaluate two keyboard layouts for carpal tunnel syndrome therapy, and to see if the efficient keyboard, Finger Relief, can be used as an adjunctive tool to other treatments or therapy for CTS for typists. Subjects who had received a diagnosis of carpal tunnel syndrome from their medical doctor and, where not contraindicated, had received confirmation of the diagnosis of carpal tunnel syndrome with a nerve conduction velocity (NCV) study participated in four typing sessions to compare onset and severity of carpal tunnel symptoms. Testing sessions alternated between keyboards. The keyboard selected for the first typing session was determined by random assignment. Twenty subjects completed all four typing sessions. The test protocol consisted of a medical history, 3 tests of the subjective pain experience of the subject (visual analogue scale / verbal rating scale, and hand diagram), 2 clinical measures of physical manifestations of swelling associated with carpal tunnel syndrome (water volume/tape measure), and a measure of the length of time spent typing on each keyboard layout - QWERTY and TheOrdinals (the Finger Relief keyboard).
Key facts
- Study ID
- NCT02101294
- Run by
- Finger Relief
- People needed
- 31
- Starts
- 1997-01-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2014-09-29
Who can join
Age: 12 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of carpal tunnel syndrome
- Completion of a nerve conduction velocity study (NCVS) within the past twelve months or a physician waiver of the NCVS
- Able to type using all fingers on the keyboard
You may not qualify if…
- Do not use all of their fingers when typing
- No active symptoms of carpal tunnel syndrome
- Unable to type, or flex and extend the fingers, for whatever reason
- Unable or unwilling to provide informed consent
- Use of pain relievers or medications during study sessions (potentially masking symptoms of median nerve entrapment)
- Unable to complete the typing activities before their symptoms (swelling associated with body ailments or metabolism) changed
- Had inconsistent subjective and objective evaluations in the preactivity test
- Threaten or abuse the investigator
- Unable to perform the activity so as to meet the minimal use requirements
- Had such injury as they had no sensation in their hands (i.e. Late stage)
- May suffer further injury (as indicated by their medical history) by attempting the typing activity
- Had non CTS related metabolic problems and upper extremity neurologic conditions, current or past, which have similar symptoms to median nerve entrapment, but which were not due to median nerve entrapment in the carpal canal
Where it is running
- Finger Relief — Springfield, Virginia, United States
Full record on ClinicalTrials.gov
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