Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

NCT04072692 | Completed

• 1 other identifier: A-ER-103-404
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Change in the grip strength

  Grip strength is measured by a grip strength meter.

  baseline, 1 month, 6 months

• Change in the pinch force

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

  baseline, 1 month, 6 months

• Change in the threshold value of sensitivity

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

  baseline, 1 month, 6 months

• 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

Study Arms (6)

1st part: The gliding properties of the tendons

NO INTERVENTION

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

1st part: The gliding properties of the median nerve

NO INTERVENTION

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.

2nd part: New hybrid rehabilitation strategy

EXPERIMENTAL

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

2nd part: Traditional strategy

EXPERIMENTAL

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

3rd part: The effect of carpal tunnel release

NO INTERVENTION

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.

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

EXPERIMENTAL

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)

Interventions

Hybrid rehabilitation training OTHER

Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.

2nd part: New hybrid rehabilitation strategy

Traditional rehabilitation training OTHER

Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.

2nd part: Traditional strategy

Wearable anti-bowstringing orthosis (WABO) OTHER

WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects without any history musculoskeletal diseases
• Patients with carpal tunnel release surgery

You may not qualify if:

• Subjects with fracture or surgery in the upper extremity.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 28, 2019
• Study Start: April 26, 2016
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

TW (1)