Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766918
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2021-02-20
Brief Title:
The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mg2 ml 3000kDa or low molecular weight HA ARTZDispo 25 mg25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None