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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Behavioral: Splinting

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Christine M. Kleinert Institute for Hand and Microsurgery
      • Contact: Millicent Horn, BS; Phone Number: 502-562-0307; Email: mhorn@cmki.org
      • Principal Investigator: Huey Tien, MD
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Kleinert, Kutz & Associates
      • Principal Investigator: Huey Tien, MD
      • Contact: Ross Gibson, BA; Phone Number: 502-562-0307; Email: rgibson@cmki.org
      • Sub-Investigator: Christiana Savvidou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Key Pinch Strength	Up to two years
Grip Strength	Up to two years
DASH questionnaire	Up to two years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; splinting; nerve decompression
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 12.0416