Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523114
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcatheter Arterial Embolization for Relief of Chronic Musculoskeletal Elbow and Foot Plantar Pain Refractory to Conservative Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single arm study in which patients with moderate to severe chronic elbow or foot plantar pain in the setting of lateral epicondylitis or plantar fascitis refractory to conservative treatment will be enrolled
The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization TAE for changes in elbow or plantar pain with 6 and 12-month follow-up
The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization TAE for changes in elbow or plantar pain with 6 and 12-month follow-up
Detailed Description:
This is a prospective single arm single center study at Chung-Ang University Hospital Patients with moderate to severe elbow or foot pain and pain refractory to at least 6 months of physician directed conservative therapy oral analgesic physical therapy or local injection treatment will be eligible for enrollment
Transcatheter arterial embolization TAE is performed after receiving informed consent and imipenem is used as an embolic material to embolize the target lesion After the procedure evaluate the VAS score and limitation of range of motion LOM of the joint area
Follow-up at 1 3 6 and 12 months after embolization and changes of VAS score and LOM are checked
Transcatheter arterial embolization TAE is performed after receiving informed consent and imipenem is used as an embolic material to embolize the target lesion After the procedure evaluate the VAS score and limitation of range of motion LOM of the joint area
Follow-up at 1 3 6 and 12 months after embolization and changes of VAS score and LOM are checked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None