Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
NCT ID: NCT04072692
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2016-04-26
2019-06-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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 interventions assigned to this group
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.
No interventions assigned to this group
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.
Hybrid rehabilitation training
Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
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.
Traditional rehabilitation training
Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
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.
No interventions assigned to this group
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.
Wearable anti-bowstringing orthosis (WABO)
WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.
Interventions
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Hybrid rehabilitation training
Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
Traditional rehabilitation training
Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
Wearable anti-bowstringing orthosis (WABO)
WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.
Eligibility Criteria
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Inclusion Criteria
2. Patients with carpal tunnel release surgery
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Locations
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National Cheng-Kung University
Tainan City, , Taiwan
Countries
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Other Identifiers
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A-ER-103-404
Identifier Type: -
Identifier Source: org_study_id
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