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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01897272
• Other study ID #: 12.0416
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2013
• Last updated: January 23, 2018
• Start date: September 2012
• Est. completion date: September 2019

Study information

• Verified date: January 2018
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Behavioral:
• Splinting
One group will have their wrist splinted after their carpal tunnel release surgery.

Locations

Country	Name	City	State
United States	Christine M. Kleinert Institute for Hand and Microsurgery	Louisville	Kentucky
United States	Kleinert, Kutz & Associates	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level	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.	Up to two years
Secondary	Key Pinch Strength		Up to two years
Secondary	Grip Strength		Up to two years
Secondary	DASH questionnaire		Up to two years