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

Christine M. Kleinert Institute for Hand and Microsurgery

Status

Unknown

Conditions

Carpal Tunnel Syndrome

Treatments

Behavioral: Splinting

Study type

Observational

Funder types

Other

Identifiers

NCT01897272

12.0416

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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