Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04072692
Collaborator
(none)
59
1
6
37.6
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hybrid rehabilitation training
  • Other: Traditional rehabilitation training
  • Other: Wearable anti-bowstringing orthosis (WABO)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
Actual Study Start Date :
Apr 26, 2016
Actual Primary Completion Date :
Jun 13, 2019
Actual Study Completion Date :
Jun 13, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the gliding features of tendons [baseline, 1 month, 6 months]

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

  2. Change in the gliding features of median nerve [baseline, 1 month, 6 months]

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

  3. Change in the grip strength [baseline, 1 month, 6 months]

    Grip strength is measured by a grip strength meter.

  4. Change in the pinch force [baseline, 1 month, 6 months]

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

  5. Change in the threshold value of sensitivity [baseline, 1 month, 6 months]

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

  6. Change in the mechanical properties of the flexor tendons [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng-Kung University Tainan Taiwan 701

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT04072692
Other Study ID Numbers:
  • A-ER-103-404
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019