Study Protocol for CTS and Keyboard Controlled Randomized Trial

NCT02101294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-09-29

Study results available
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Summary

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).

Conditions

  • Carpal Tunnel Syndrome

Interventions

DEVICE

Interossei Lumbricals Neuro Interface

Finger Relief's keyboard home row layout \[actual home row placement order: asdeihotlrn\], plus substitutions on the upper row \[qwfgjyuk;p\] and bottom row \[zxcvb'm,.\] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness.

DEVICE

Standard QWERTY keyboard

Report of onset and severity symptoms of carpal tunnel syndrome when typing with QWERTY keyboard and the Finger Relief device.

Sponsors & Collaborators

  • Finger Relief

    lead OTHER

Principal Investigators

  • John I Choate, J.D. · Association of Repetitive Motion Syndromes

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101294 on ClinicalTrials.gov