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

NCT01897272 | Unknown DMC

• 1 other identifier: 12.0416
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

carpal tunnel syndrome; splinting; nerve decompression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Key Pinch Strength

  Up to two years

• Grip Strength

  Up to two years

• DASH questionnaire

  Up to two years

Study Arms (2)

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

No Splinting After Surgery

This group will not be splinted after the short-incision carpal tunnel release

Interventions

Splinting BEHAVIORAL

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

Splinting After Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine M. Kleinert Institute for Hand and Microsurgery: lead

Study Sites (2)

Christine M. Kleinert Institute for Hand and Microsurgery

Louisville, Kentucky, 40202, United States

RECRUITING

Kleinert, Kutz & Associates

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Huey Tien, MD

  Christine M. Kleinert Institute for Hand and Microsurgery

  PRINCIPAL INVESTIGATOR

• Millicent L Horn, BS

  Christine M. Kleinert Institute for Hand and Microsurgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: July 11, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (2)