The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome Clinical Trial
Official title:
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
| Verified date | August 2019 |
| Source | National Cheng-Kung University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | June 13, 2019 |
| Est. primary completion date | June 13, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Cheng-Kung University | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| National Cheng-Kung University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the gliding features of tendons | The gliding features of tendons is measured by ultrasound images of the flexor tendons | baseline, 1 month, 6 months | |
| Primary | Change in the gliding features of median nerve | The gliding features of median nerve is measured by ultrasound images of the flexor tendons | baseline, 1 month, 6 months | |
| Primary | Change in the grip strength | Grip strength is measured by a grip strength meter. | baseline, 1 month, 6 months | |
| Primary | Change in the pinch force | Three types of pinch force are measured by a pinch gauge. | baseline, 1 month, 6 months | |
| Primary | Change in the threshold value of sensitivity | Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing. | baseline, 1 month, 6 months | |
| Primary | 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 | baseline, 1 month, 6 months |