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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01853969
Other study ID # 101131
Secondary ID
Status Completed
Phase N/A
First received May 9, 2013
Last updated September 15, 2015
Start date May 2013
Est. completion date June 2015

Study information

Verified date September 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study will investigate how soon a patient's typing proficiency returns to their pre-operative levels following carpal tunnel release surgery. In order to determine this, patients will undergo typing tests at different time points that will record their typing accuracy and speed. The results will then be compared to determine on average how soon a person returns to their pre-operative baseline results.


Description:

Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist. It causes such symptoms as numbness, tingling, weakness, muscle damage, and pain. If non-operative treatments do not work generally patients go on to carpal tunnel release surgery in which the transverse carpal ligament is released. After surgery patients usually return to work with no restrictions within six weeks. Patients often ask how soon they are able to return to typing after surgery, and what their typing ability will be like after surgery. Currently there are no studies that evaluate how long it takes for patient's typing skills to return to that of the pre-operative skill level. We would like to answer that question by comparing typing results from different time points including a baseline prior to surgery. We additionally seek to identify which patient characteristics are predictive of a faster return of typing proficiency.

An additional innovative aspect of this project is the use of a web-based typing test that will be used in the assessment of patient typing proficiency. We will additionally use a web-based model for the collection of our survey data.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients set to undergo carpal tunnel release

- Patients who have a positive EMG test

- Patients must have access to a computer with internet access

- Patients must have an email account

- Patients must be between the ages of 20-70

- Patients that meet typing test requirements

- Must type weekly

- Typing proficiency of 30 wpm at time of pre-operative appointment

- Must use all fingers when typing

- Can read text in font Times New Roman size 14

Exclusion Criteria:

- People who cannot read or write

- People who do not meet inclusion criteria

- Patients who do not speak English

- Patients unwilling or unable to return for follow-up visits prescribed by the study protocol

- Patients who qualify for inclusion in the study, but refuse to participate.

- Patients with concurrent, ipsilateral confounding hand or upper extremity pathology such as trigger finger, ganglion cyst, painful arthritis, etc.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Typing assessment


Locations

Country Name City State
United States Vanderbilt University Hand & Upper Extremity Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Orthopedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in typing test measurements (speed and accuracy) Each patient will complete a preoperative typing test (at their home) prior to undergoing carpal tunnel release surgery. The patient will then take the same typing test at the following time points postoperatively: 8-10days, 2wks, 3wks, 4wks, 5wks, 6wks, 8wks, 12wks. The change in speed and accuracy will be assessed by comparing the preoperative (baseline) typing test results to the postoperative typing test results. Preoperative, Postoperative: 8-10days, 2wks, 3wks, 4wks, 5wks, 6wks, 8wks, 12wks No
See also
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Completed NCT02313675 - Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries Phase 4
Completed NCT02766114 - Carpal Tunnel Release Through Mini Transverse Approach N/A
Recruiting NCT04460521 - The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome Phase 4