Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342245
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy a Multicentre Prospective Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
AT RCT
Brief Summary:
This is a prospective randomized double-blinded placebo-controlled superiority trial with two parallel groups and a 11 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy All participants will be randomized into two groups the intervention group n24 radiofrequency coblation micro-tenotomy endoscopic Achilles debridement and the control group n24 endoscopic Achilles debridement only Adults age 18 with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist athletic trainer Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention Criteria for discontinuing or modifying allocated interventions Strategies to improve adherence to interventions Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care Outocme measure will use VISA-A pain scores ultrasound measurement of thickness and vascularity calf muscle strength and ankle range of motion
Detailed Description:
None
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