Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01897272 |
Recruitment Status
:
Recruiting
First Posted
: July 11, 2013
Last Update Posted
: January 25, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Carpal Tunnel Syndrome | Behavioral: Splinting |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 6 Months |
Official Title: | Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | September 2019 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
Behavioral: Splinting
One group will have their wrist splinted after their carpal tunnel release surgery.
|
No Splinting After Surgery
This group will not be splinted after the short-incision carpal tunnel release
|
- Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level [ Time Frame: 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.
- Key Pinch Strength [ Time Frame: Up to two years ]
- Grip Strength [ Time Frame: Up to two years ]
- DASH questionnaire [ Time Frame: Up to two years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897272
United States, Kentucky | |
Christine M. Kleinert Institute for Hand and Microsurgery | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Millicent Horn, BS 502-562-0307 mhorn@cmki.org | |
Principal Investigator: Huey Tien, MD | |
Kleinert, Kutz & Associates | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Ross Gibson, BA 502-562-0307 rgibson@cmki.org | |
Principal Investigator: Huey Tien, MD | |
Sub-Investigator: Christiana Savvidou, MD |
Principal Investigator: | Huey Tien, MD | Christine M. Kleinert Institute for Hand and Microsurgery | |
Study Chair: | Millicent L Horn, BS | Christine M. Kleinert Institute for Hand and Microsurgery |
Responsible Party: | Christine M. Kleinert Institute for Hand and Microsurgery |
ClinicalTrials.gov Identifier: | NCT01897272 History of Changes |
Other Study ID Numbers: |
12.0416 |
First Posted: | July 11, 2013 Key Record Dates |
Last Update Posted: | January 25, 2018 |
Last Verified: | January 2018 |
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
carpal tunnel syndrome splinting nerve decompression |
Additional relevant MeSH terms:
Carpal Tunnel Syndrome Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries |