Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT06814769
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid and Articular Pain
Sponsor:
University of Catanzaro
Organization:
Study Overview
Official Title:
Hyaluronic Acid in the Management of Articular Pain
Status:
COMPLETED
Status Verified Date:
2025-02
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:
HApain
Brief Summary:
This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2
Detailed Description:
This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.
The first efficacy end-point will be:
the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2
The first efficacy end-point will be:
the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2
Study Oversight
Has Oversight DMC:
False
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?: