Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620874
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Comparison of the Efficacy of Ultrasound-Guided Injections of Saline High-Concentration Dextrose and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis A Randomized Double-Blind Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Efficacy of Ultrasound-Guided Injections of Saline High-Concentration Dextrose and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis A Randomized Double-Blind Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to evaluate the effectiveness of STABHA high-concentration glucose water and saline injections in treating knee osteoarthritis with medial collateral ligament lesions This prospective double-blind randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department
The main questions it aims to answer are
1 Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline
2 What side effects do participants experience with these treatments
Participants will be randomly divided into three groups STABHA high-concentration glucose water and saline In addition to routine intra-articular hyaluronic acid injections each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee with a two-week interval All participants will also undergo a 4-week physical therapy program
Participants will
1 Receive two ultrasound-guided injections over two weeks
2 Undergo 4 weeks of physical therapy
3 Return for follow-up assessments at 1 and 3 months including the WOMAC osteoarthritis index pain score KOOS knee outcome score knee range of motion and knee ultrasound examination
The main questions it aims to answer are
1 Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline
2 What side effects do participants experience with these treatments
Participants will be randomly divided into three groups STABHA high-concentration glucose water and saline In addition to routine intra-articular hyaluronic acid injections each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee with a two-week interval All participants will also undergo a 4-week physical therapy program
Participants will
1 Receive two ultrasound-guided injections over two weeks
2 Undergo 4 weeks of physical therapy
3 Return for follow-up assessments at 1 and 3 months including the WOMAC osteoarthritis index pain score KOOS knee outcome score knee range of motion and knee ultrasound examination
Detailed Description:
None
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