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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splinting After Surgery | This group will be fitted for a splint and given instructions on wearing their splint after their short-incision Carpal Tunnel Release |
| |
| No Splinting After Surgery | This group will not be splinted after the short-incision carpal tunnel release |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splinting | Behavioral | One group will have their wrist splinted after their carpal tunnel release surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Key Pinch Strength | Up to two years | |
| Grip Strength | Up to two years | |
| DASH questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Huey Tien, MD | Christine M. Kleinert Institute for Hand and Microsurgery | Principal Investigator |
| Millicent L Horn, BS | Christine M. Kleinert Institute for Hand and Microsurgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christine M. Kleinert Institute for Hand and Microsurgery | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Up to two years |
| Kleinert, Kutz & Associates | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |