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

January 23, 2018 updated by: Christine M. Kleinert Institute for Hand and Microsurgery

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Christine M. Kleinert Institute for Hand and Microsurgery
        • Contact:
        • Principal Investigator:
          • Huey Tien, MD
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Kleinert, Kutz & Associates
        • Principal Investigator:
          • Huey Tien, MD
        • Contact:
        • Sub-Investigator:
          • Christiana Savvidou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Key Pinch Strength
Time Frame: Up to two years
Up to two years
Grip Strength
Time Frame: Up to two years
Up to two years
DASH questionnaire
Time Frame: Up to two years
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christine M. Kleinert Institute for Hand and Microsurgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12.0416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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