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Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

Primary Purpose

The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hybrid rehabilitation training
Traditional rehabilitation training
Wearable anti-bowstringing orthosis (WABO)
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cheng-Kung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

Experimental

Experimental

No Intervention

Experimental

Arm Label

1st part: The gliding properties of the tendons

1st part: The gliding properties of the median nerve

2nd part: New hybrid rehabilitation strategy

2nd part: Traditional strategy

3rd part: The effect of carpal tunnel release

3rd part: Wearable anti-bowstringing orthosis (WABO)

Arm Description

No intervention. Subjects are measured by ultrasound under 5 different postures of the hand for forty minutes.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the gliding features of tendons
The gliding features of tendons is measured by ultrasound images of the flexor tendons
Change in the gliding features of median nerve
The gliding features of median nerve is measured by ultrasound images of the flexor tendons
Change in the grip strength
Grip strength is measured by a grip strength meter.
Change in the pinch force
Three types of pinch force are measured by a pinch gauge.
Change in the threshold value of sensitivity
Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.
Change in the mechanical properties of the flexor tendons
The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons

Secondary Outcome Measures

Full Information

First Posted
August 27, 2019
Last Updated
August 27, 2019
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04072692
Brief Title
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
Official Title
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2016 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
June 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st part: The gliding properties of the tendons
Arm Type
No Intervention
Arm Description
No intervention. Subjects are measured by ultrasound under 5 different postures of the hand for forty minutes.
Arm Title
1st part: The gliding properties of the median nerve
Arm Type
No Intervention
Arm Description
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.
Arm Title
2nd part: New hybrid rehabilitation strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
2nd part: Traditional strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
3rd part: The effect of carpal tunnel release
Arm Type
No Intervention
Arm Description
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.
Arm Title
3rd part: Wearable anti-bowstringing orthosis (WABO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hybrid rehabilitation training
Intervention Description
Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation training
Intervention Description
Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
Intervention Type
Other
Intervention Name(s)
Wearable anti-bowstringing orthosis (WABO)
Intervention Description
WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.
Primary Outcome Measure Information:
Title
Change in the gliding features of tendons
Description
The gliding features of tendons is measured by ultrasound images of the flexor tendons
Time Frame
baseline, 1 month, 6 months
Title
Change in the gliding features of median nerve
Description
The gliding features of median nerve is measured by ultrasound images of the flexor tendons
Time Frame
baseline, 1 month, 6 months
Title
Change in the grip strength
Description
Grip strength is measured by a grip strength meter.
Time Frame
baseline, 1 month, 6 months
Title
Change in the pinch force
Description
Three types of pinch force are measured by a pinch gauge.
Time Frame
baseline, 1 month, 6 months
Title
Change in the threshold value of sensitivity
Description
Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.
Time Frame
baseline, 1 month, 6 months
Title
Change in the mechanical properties of the flexor tendons
Description
The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons
Time Frame
baseline, 1 month, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects without any history musculoskeletal diseases Patients with carpal tunnel release surgery Exclusion Criteria: Subjects with fracture or surgery in the upper extremity.
Facility Information:
Facility Name
National Cheng-Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

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Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

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