Recruiting

Observational Study

Sponsor:

Christine M. Kleinert Institute for Hand and Microsurgery

Code:

NCT01897272

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Splinting

Study Details

Brief summary:

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT01897272

Start date

Sep, 2012

Status verified date

Jan, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Splinting

One group will have their wrist splinted after their carpal tunnel release surgery.

Primary outcome measure

  • Ultrasound Biomicroscopy of the cross section area of the median nerve at the pisiform level [ Time Frame: Up to two years ]

Central Contacts and Locations

Locations

Christine M. Kleinert Institute for Hand and Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Millicent Horn, BS

502-562-0307mhorn@cmki.org

Principal Investigator:

Huey Tien, MD

Kleinert, Kutz & Associates

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Ross Gibson, BA

502-562-0307rgibson@cmki.org

Principal Investigator:

Huey Tien, MD

More Information

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • carpal tunnel syndrome
  • splinting
  • nerve decompression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine M. Kleinert Institute for Hand and Microsurgery on 2018-01-25.