Clinical Trials Directory

Trials / Completed

CompletedNCT03381521

The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

The Clinical Volume Effect of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Tri-Service General Hospital · Academic / Other
Sex
All
Age
20 Years – 80 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. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage. However, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies Hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with CTS.

Detailed description

After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were inclused and randomized into three groups. Group A, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure. As a result, patients were blinded to the treatment condition. 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 global assessment of treatment. The evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound-guided nerve hydrodissectionUltrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
PROCEDUREUltrasound-guided nerve hydrodissectionUltrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
DEVICEUltrasoundThe ultrasound was used to measure cross-sectional area and injection guidance
DRUGNormal salineThe normal saline was used for injection solution

Timeline

Start date
2018-08-01
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2017-12-22
Last updated
2023-01-13

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03381521. Inclusion in this directory is not an endorsement.