The Effect of Hydrodissection for Carpal Tunnel Syndrome

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-04-15

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 trail to assess the effect after 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 intervention group received one-dose ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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 and 3rd 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

DOUBLE

Participants Investigators

Study Groups

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Normal saline hydrodissection

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

Group Type EXPERIMENTAL

Ultrasound-guided hydrodissection

Intervention Type PROCEDURE

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

Ultrasound

Intervention Type DEVICE

Normal Saline

Intervention Type DRUG

Normal saline

Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region

Group Type PLACEBO_COMPARATOR

Placebo ultrasound-guided injection

Intervention Type PROCEDURE

Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Ultrasound

Intervention Type DEVICE

Normal Saline

Intervention Type DRUG

Interventions

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Ultrasound-guided hydrodissection

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

Intervention Type PROCEDURE

Placebo ultrasound-guided injection

Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Intervention Type PROCEDURE

Ultrasound

Intervention Type DEVICE

Normal Saline

Intervention Type DRUG

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

Yes