NCT02809261

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided perineural injection with 5% dextrose	Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
PROCEDURE	Ultrasound-guided perineural injection with normal saline	Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
DRUG	Normal Saline	Normal saline is safe for perineural injection.
DRUG	5% Dextrose	5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2016-06-22
• Last updated: 2017-12-19

Locations

1 site across 1 country: Taiwan