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

• Conditions: Carpal Tunnel Syndrome
• Interventions: Behavioral: Splinting

• Registration Number: NCT01897272
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Splinting After Surgery	Splinting	This group will be fitted for a splint and given instructions on wearing their splint after their short-incision Carpal Tunnel Release

Primary Outcome Measures

Name	Time	Method
Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level	Up to two years	This is a high resolution ultrasound used to determine the distance between the surface and the median nerve. This device is a research device not approved for clinical use, but is considered a non-significant risk (NSR) device. This machine is just like a regular ultrasound machine. The primary difference is that the frequence of the soundwaves is higher than a standard ultrasound machine. At this time, the machine is experimental, and it is not currently approved by the FDA for clinical use. However, this same technology is used in similar devices by opthamologists to image retinas. It has been used on hudnreds of humans for research studies.

Secondary Outcome Measures

Name	Time	Method
DASH questionnaire	Up to two years
Key Pinch Strength	Up to two years
Grip Strength	Up to two years

Trial Locations

Locations (2)

Kleinert, Kutz & Associates; 🇺🇸 Louisville, Kentucky, United States

Christine M. Kleinert Institute for Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States