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Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

Not Applicable
Completed
Conditions
The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome
Interventions
Other: Hybrid rehabilitation training
Other: Traditional rehabilitation training
Other: Wearable anti-bowstringing orthosis (WABO)
Registration Number
NCT04072692
Lead Sponsor
National Cheng-Kung University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2nd part: New hybrid rehabilitation strategyHybrid rehabilitation trainingThe 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.
2nd part: Traditional strategyTraditional rehabilitation trainingThe 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.
3rd part: Wearable anti-bowstringing orthosis (WABO)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.
Primary Outcome Measures
NameTimeMethod
Change in the gliding features of tendonsbaseline, 1 month, 6 months

The gliding features of tendons is measured by ultrasound images of the flexor tendons

Change in the mechanical properties of the flexor tendonsbaseline, 1 month, 6 months

The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons

Change in the gliding features of median nervebaseline, 1 month, 6 months

The gliding features of median nerve is measured by ultrasound images of the flexor tendons

Change in the threshold value of sensitivitybaseline, 1 month, 6 months

Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.

Change in the grip strengthbaseline, 1 month, 6 months

Grip strength is measured by a grip strength meter.

Change in the pinch forcebaseline, 1 month, 6 months

Three types of pinch force are measured by a pinch gauge.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

National Cheng-Kung University

🇨🇳

Tainan, Taiwan

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