Study Protocol for CTS and Keyboard Controlled Randomized Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02101294
• Date of registration: 24/03/2014
• Prospective Registration: No
• Primary sponsor: Finger Relief
• Public title: Study Protocol for CTS and Keyboard Controlled Randomized Trial
• Scientific title: Study Protocol for Carpal Tunnel Syndrome and Typing Keyboard: Controlled Randomized Trial
• Date of first enrolment: January 1997
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02101294
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: John I Choate, J.D.
• Affiliation: Association of Repetitive Motion Syndromes

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 12 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Carpal Tunnel Syndrome

Intervention(s)

Device: Standard QWERTY keyboard

Device: Interossei Lumbricals Neuro Interface

Primary Outcome(s)

Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome) [Time Frame: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside]

Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS [Time Frame: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside]

Secondary Outcome(s)

Measurement of Increase in Wrist Swelling Following FingerRelief Typing [Time Frame: Pre and Post]

Measurement of Wrist Swelling Following Cessation of QWERTY Typing [Time Frame: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside]

Secondary ID(s)

1997-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02101294