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

Purpose

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.

Condition	Intervention
Carpal Tunnel Syndrome	Behavioral: Splinting


Study Type:	Observational [Patient Registry]
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Sodium polystyrene sulfonate

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome

U.S. FDA Resources

Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:

Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Key Pinch Strength [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
Grip Strength [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
DASH questionnaire [ Time Frame: Up to two years ] [ Designated as safety issue: No ]


Estimated Enrollment:	40
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897272

Locations


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

Sponsors and Collaborators

Christine M. Kleinert Institute for Hand and Microsurgery

Investigators


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

More Information


Responsible Party:	Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:	NCT01897272 History of Changes
Other Study ID Numbers:	12.0416
Study First Received:	June 13, 2013
Last Updated:	April 14, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 29, 2016