Different Sessions of Perineural Injection With Dextrose 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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-03-31

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. The technique of perineural injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However, the evidence and reference of PIT and nerve hydrodissection are very seldom until our series researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection. However, the accumulative effect and long-term effect (more than 6 months) of PIT is still unknown. Hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is to evaluate the long-term effect and safety of PIT (one year follow-up).

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Detailed Description

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After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were includes and randomized into three groups. Group A, patients received two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline. 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, nerve conduction velocity of the median nerve, and Global assessment of treatment. The evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.

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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Two-sessions of ultrasound-guided PIT

two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)

Group Type EXPERIMENTAL

two-sessions of ultrasound-guided PIT

Intervention Type PROCEDURE

two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)

One-session of ultrasound-guided PIT

one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)

Group Type ACTIVE_COMPARATOR

One-sessions of ultrasound-guided PIT

Intervention Type PROCEDURE

One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)

Two-session of ultrasound-guided nerve hydrodissection

two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Group Type PLACEBO_COMPARATOR

Placebo ultrasound-guided injection with nerve hydrodissection

Intervention Type PROCEDURE

Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Interventions

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two-sessions of ultrasound-guided PIT

two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)

Intervention Type PROCEDURE

One-sessions of ultrasound-guided PIT

One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)

Intervention Type PROCEDURE

Placebo ultrasound-guided injection with nerve hydrodissection

Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

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

Yes