Comparison of Difference Hydrodissection for CTS

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2019-08-30

Brief Summary

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Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trial to assess the effect of different method of ultrasound-guided hydrodissection in patients with CTS.

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Detailed Description

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After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in short-axis group received one-dose ultrasound-guided hydrodissection with short-axis approach and long-axis group received one-dose ultrasound-guided injection with long-axis approach. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

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

SINGLE

Participants

Study Groups

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Short-axis hydrodissection

Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve

Group Type EXPERIMENTAL

Ultrasound-guided short-axis hydrodissection with 5cc normal saline

Intervention Type PROCEDURE

Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve

Long-axis hydrodissection

Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve

Group Type ACTIVE_COMPARATOR

Ultrasound-guided long-axis hydrodissection with 3cc normal saline

Intervention Type PROCEDURE

Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve

Interventions

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Ultrasound-guided short-axis hydrodissection with 5cc normal saline

Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve

Intervention Type PROCEDURE

Ultrasound-guided long-axis hydrodissection with 3cc normal saline

Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No