The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome

Study Overview
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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. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.

Detailed Description
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After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. 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, 4th, 8th, 12th, 16th and 24th week after the treatment.

Official Title
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The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Ultrasound-guided perineural injection with 5% dextrose
* Procedure: Ultrasound-guided perineural injection with normal saline
* Drug: Normal Saline
* Drug: 5% Dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-85 year-old. Diagnosis was confirmed using an electrophysiological study and ultrasonography Exclusion Criteria: Cancer Coagulopathy Pregnancy Inflammation status Cervical radiculopathy Polyneuropathy, brachial plexopathy Thoracic outlet syndrome Previously undergone wrist surgery or steroid injection for CTS

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perineural injection with 5% dextrose<br>Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve. | Procedure: Ultrasound-guided perineural injection with 5% dextrose<br>* Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.<br>Drug: 5% Dextrose<br>* 5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.<br>|
| Placebo Comparator: Perineural injection with normal saline<br>Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve. | Procedure: Ultrasound-guided perineural injection with normal saline<br>* Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.<br>Drug: Normal Saline<br>* Normal saline is safe for perineural injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | 
| Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal Tunnel Syndrome, Perineural injection, Dextrose