Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

August 27, 2019 updated by: National Cheng-Kung University Hospital

The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts.

The first part is an observational study. The aim of the first part is to attempts to measure the gliding and morphological characteristics of the flexor tendons and median nerve in the longitudinal or cross-sectional directions via the ultrasonographical images incorporating with the motion capture experiment of the wrist and fingers. The gliding and morphological features of the tendons and nerve will be compared under different postures or movement patterns of the wrist and hand.

The second part is an interventional study. The aim of the first part is to establishes a novel hybrid rehabilitation protocol which combines the tendon gliding exercise with nerve mobilization to treat either the trigger digit or the carpal tunnel syndrome. A randomized controlled trial to investigate the short-term treatment effect and the follow-up examination will be carried out as well.

The third part is an observational study. The aim of the first part is to investigate the effects of carpal tunnel release on the hand performances from functional perspectives. In addition, a novel wrist orthosis will be developed to eliminate the bowstringing effect of the flexor tendons after carpal tunnel release.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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

  • Taiwan
      • Tainan, Taiwan, 701
        • National Cheng-Kung University

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects without any history musculoskeletal diseases
  2. Patients with carpal tunnel release surgery

Exclusion Criteria:

  • Subjects with fracture or surgery in the upper extremity.

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1st part: The gliding properties of the tendons
No intervention. Subjects are measured by ultrasound under 5 different postures of the hand for forty minutes.
No Intervention: 1st part: The gliding properties of the median nerve
No intervention. Subjects are measured by ultrasound under under 6 different postures of the wrist and hand and 5 different movement patterns of the wrist and hand for forty minutes.
Experimental: 2nd part: New hybrid rehabilitation strategy

The program includes pre-test, 8 times training, post-test and follow-up test.

For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes.

For post-test, the same procedure is repeated again after completing all training.

For follow-up, the same procedure is repeated again 6 months after completing all training.

After pre-test, 8 times hybrid rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes.
Other: Hybrid rehabilitation training
Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
Experimental: 2nd part: Traditional strategy

The program includes pre-test, 8 times training, post-test and follow-up test.

For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes.

For post-test, the same procedure is repeated again after completing all training.

For follow-up, the same procedure is repeated again 6 months after completing all training.

After pre-test, 8 times traditional rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes.
Other: Traditional rehabilitation training
Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
No Intervention: 3rd part: The effect of carpal tunnel release

No intervention. The program includes pre-test, post-test and two times follow-up tests.

For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes.

For post-test, subjects perform the functional assessment of both hands one week after carpal tunnel release surgery. It takes 20 minutes.

For first follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands one month after carpal tunnel release surgery. It takes 40 minutes.

For second follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands two month after carpal tunnel release surgery. It takes 40 minutes.
Experimental: 3rd part: Wearable anti-bowstringing orthosis (WABO)

The program includes pre-test, post-test and two times follow-up tests.

For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes.

Subjects wear WABO in the morning and a splint at night within a week after carpal tunnel release surgery.

For post-test, subjects perform the functional assessment of both hands with and without wearing WABO and a splint one week after carpal tunnel release surgery. It takes 40 minutes.

From the third weeks after carpal tunnel release surgery, subjects wear WABO only in the morning.

For first follow-up, the same procedure in pre-test is repeated again one month after carpal tunnel release surgery. It takes 40 minutes.

For second follow-up, the same procedure in pre-test is repeated again two month after carpal tunnel release surgery.
Other: Wearable anti-bowstringing orthosis (WABO)
WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the gliding features of tendons
Time Frame: baseline, 1 month, 6 months
The gliding features of tendons is measured by ultrasound images of the flexor tendons
baseline, 1 month, 6 months
Change in the gliding features of median nerve
Time Frame: baseline, 1 month, 6 months
The gliding features of median nerve is measured by ultrasound images of the flexor tendons
baseline, 1 month, 6 months
Change in the grip strength
Time Frame: baseline, 1 month, 6 months
Grip strength is measured by a grip strength meter.
baseline, 1 month, 6 months
Change in the pinch force
Time Frame: baseline, 1 month, 6 months
Three types of pinch force are measured by a pinch gauge.
baseline, 1 month, 6 months
Change in the threshold value of sensitivity
Time Frame: baseline, 1 month, 6 months
Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.
baseline, 1 month, 6 months
Change in the mechanical properties of the flexor tendons
Time Frame: baseline, 1 month, 6 months
The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons
baseline, 1 month, 6 months

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

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 (Actual)

April 26, 2016

Primary Completion (Actual)

June 13, 2019

Study Completion (Actual)

June 13, 2019

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-103-404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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