Clinical trial NCT01897272: Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study
Official title: Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
splinting
nerve decompression
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are looking for patients who are old enough to give informed consent who are preparing to have nerve decompression with short incision for their carpal tunnel syndrome.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level
timeFrame: Up to two years
Secondary outcomes:
measure: Key Pinch Strength
timeFrame: Up to two years
measure: Grip Strength
timeFrame: Up to two years
measure: DASH questionnaire
timeFrame: Up to two years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Institute for Hand and Microsurgery
state: Kentucky
city: Louisville
country: United States
facility: Kleinert, Kutz & Associates
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Huey Tien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Millicent L Horn, BS
role: STUDY_CHAIR
References: