The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

NCT ID: NCT03598322

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2019-07-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dextrose 1mL

Dextrose injection, Dextrose 1mL, active comparator

Group Type ACTIVE_COMPARATOR

Dextrose 1mL injection

Intervention Type PROCEDURE

Dextrose 1mL injection and hydrodissection for CTS

Dextrose 2mL

Dextrose injection, Dextrose 2mL

Group Type EXPERIMENTAL

Dextrose 2mL injection

Intervention Type PROCEDURE

Dextrose 2mL injection

Dextrose 4mL

'Dextrose injection, Dextrose 4mL

Group Type EXPERIMENTAL

Dextrose 4mL injection

Intervention Type PROCEDURE

Dextrose 4mL injection

Interventions

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Dextrose 1mL injection

Dextrose 1mL injection and hydrodissection for CTS

Intervention Type PROCEDURE

Dextrose 2mL injection

Dextrose 2mL injection

Intervention Type PROCEDURE

Dextrose 4mL injection

Dextrose 4mL injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 20-80
* Electrophysiological diagnosis of carpal tunnel syndrome
* At least one of the following two:

1. Tenderness or numbness over median nerve innervated dermatome over 2 months
2. 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chueh Hung Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.

Reference Type DERIVED
PMID: 33391002 (View on PubMed)

Other Identifiers

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201711014RINA

Identifier Type: -

Identifier Source: org_study_id

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