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NCT Number: NCT04072692

Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

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.

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Key information

Conditions

The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University

Tainan, 701, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects with fracture or surgery in the upper extremity.

Treatment and study plan

Hybrid rehabilitation training

Other

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

Traditional rehabilitation training

Other

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

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.

Primary outcomes

  1. Change in the gliding features of tendons

    Time frame: 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

    Time frame: 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

    Time frame: baseline, 1 month, 6 months

    Grip strength is measured by a grip strength meter.

  4. Change in the pinch force

    Time frame: baseline, 1 month, 6 months

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

  5. Change in the threshold value of sensitivity

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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