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NCT Number: NCT03598322

The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

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Key information

Conditions

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

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20-80
  • Electrophysiological diagnosis of carpal tunnel syndrome
  • At least one of the following two:
  • Tenderness or numbness over median nerve innervated dermatome over 2 months
  • Phalen test or Tinel sign or flick sign positive

Exclusion criteria

  • History of wrist surgery
  • Wrist trauma in recent two years
  • Received wrist injection in recent three months
  • History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
  • History of DM, thyroid disorder or autoimmune disease
  • Unable to cooperate with interview, examination or injection

Treatment and study plan

Dextrose 1mL injection

Procedure

Dextrose 1mL injection and hydrodissection for CTS

Dextrose 2mL injection

Procedure

Dextrose 2mL injection

Dextrose 4mL injection

Procedure

Dextrose 4mL injection

Primary outcomes

  1. Change of Visual analog scale (VAS)

    Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks

    Change of Visual analog scale (VAS), from Baseline

Secondary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)

    Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks

    Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5

  2. QuickDASH

    Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks

    QuickDASH (The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)), 11 items with each item scale 1-5

  3. MSK US finding

    Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks

    Cross-sectional area of median nerve

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Sep 6, 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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