Carpal Tunnel ReleaseNCT01853969
Typing Proficiency Following Carpal Tunnel Release
An observational study of Carpal Tunnel Release, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Carpal Tunnel Release
- What is being tested?
- Typing assessment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vanderbilt Hand \& Upper Extremity Center Outpatient Clinic
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Hand & Upper Extremity Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed 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.
- Conditions
- Carpal Tunnel Release
- Being tested
- Typing assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typing assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Patients who have carpal tunnel release surgery | Not described Receives: Other: Typing assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative, Postoperative: 8-10days, 2wks, 3wks, 4wks, 5wks, 6wks, 8wks, 12wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel ReleaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Principal investigator, Donald Lee, Vanderbilt University
- Investigators
- Donald H Lee, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853969
- Sponsor's protocol ID
- 101131
- Status last verified
- Sep 2015
- First submitted
- 9 May 2013
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typing Proficiency Following Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT01853969
- Acronym / sponsor ID
- 101131
- Conditions
- Carpal Tunnel Release
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have carpal tunnel release surgery | – | Other: Typing assessment |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vanderbilt Hand \& Upper Extremity Center Outpatient Clinic
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Typing assessment | Other | Patients who have carpal tunnel release surgery |
Primary outcome
Change in typing test measurements (speed and accuracy)
Time frame: Preoperative, Postoperative: 8-10days, 2wks, 3wks, 4wks, 5wks, 6wks, 8wks, 12wks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald H Lee, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Release, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in typing test measurements (speed and accuracy) (time frame: Preoperative, Postoperative: 8-10days, 2wks, 3wks, 4wks, 5wks, 6wks, 8wks, 12wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.