Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/27/2018
Start Date:September 2012
End Date:September 2019

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Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study

This research study is for patients who are schedule to have carpal tunnel release surgery.
The investigators have developed this study in order to determine if post-operative splinting
is effective in improvement of patient outcomes after this surgical procedure. The study is
being conducted under the direction of Huey Tien, MD. The purpose of this study is to
determine if post-operative splinting is effective in improving patient outcomes after having
short-incision carpal tunnel release. The investigators will randomize each patient into
group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have
the same outcome measurements done to determine the best outcome of the two groups.

Your participation in this study will last for five office visits of approximately 30 minutes
each. If you decide to participate in this study, we would first have you come to clinic
where you would undergo some standard measurements. This includes measuring grip and key
pinch strength and completing a patient questionnaire. During your visits we will scan the
cross-sectional area of the median nerve at the pisiform bone level to determine the level of
CTS with the Ultrasound Biomiscroscopy machine (Vevo 2100). This is a new technique with a
machine similar to a regular ultrasound machine. The primary difference is that the frequency
of soundwaves is higher than a standard ultrasound machine. There are no known significant
risks associated with the use of this machine. At this time the machine is experimental, and
is not currently approved by the FDA for clinical use. However, this device is not considered
to pose significant risk. Candidates for this study must have been diagnosed with single
carpal tunnel syndrome and are going to receive nerve decompression with short incision, over
the age of 18, and able to give informed consent to participate in a research study.

Inclusion Criteria:

- Patients who were diagnosed with carpal tunnel syndrome and are going to receive nerve
decompression with short incision

- The Criteria of CTS

- Numbness, tingling, pain and night symptoms in median nerve distribution

- Positive Tinel signs over the median nerve at the Carpal Tunnel

- Negative Tinel signs at the Supraclavicular and Infraclavicular areas

- Positive Carpal Tunnel Tests

- Electrophysiological changes (confirmed with NCT)

- Over the age of 18

- Ability to give informed consent to participate in a research study

Exclusion Criteria:

- Patients with peripheral neuropathy of the median nerve secondary to trauma, external
compressions (tumours, bone malunion) or other non-compressive causes.

- Patients with the presence of Thoracic Outlet Syndrome (Tinel must be negative at the
Supraclavicular and Infraclavicular areas)

- Patients with the presence of Cervical Disc disease

- Patients with another site of compression (such as pronator teres compression)

- Patients who have had previous carpal tunnel release on the same hand

- Patients under the age of 18
We found this trial at
2
sites
Louisville, Kentucky 40202
Principal Investigator: Huey Tien, MD
Phone: 502-562-0307
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Louisville, KY
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Louisville, Kentucky 40202
Principal Investigator: Huey Tien, MD
Phone: 502-562-0307
?
mi
from
Louisville, KY
Click here to add this to my saved trials