NCT04766918

The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome

The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare. We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.

Detailed description

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
PROCEDURE	Sono-guided injection with high molecular weight hyaluronic acid	Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve
PROCEDURE	Sono-guided injection with low molecular weight hyaluronic acid	Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-02-23
• Last updated: 2024-04-10

Locations

1 site across 1 country: Taiwan