Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301958
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Brief Title:
Dextrose Prolotherapy on Articular Cartilage
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
The Effects and Molecular Mechanisms of Dextrose Prolotherapy on Articular Cartilage
Status:
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:
None
Brief Summary:
Dextrose prolotherapy is a controversial injection therapy in sports medicine Currently 25 hypertonic glucose solution is commonly used in clinical practice Although this method has a certain therapeutic effect there is still some controversy about the molecular mechanism of dextrose prolotherapy In the past it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the self-healing mechanism However some studies have pointed out that this treatment can cause cell apoptosis In my clinical work I often perform dextrose prolotherapy I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients We believe that the concentration of 25 hypertonic glucose solution should show a stepwise decrease in the joint cavity Our preliminary cell experiment results using 2-fold serial dilutions of 25 glucose solution showed that 25 12 and 6 glucose solution will trigger the apoptosis of chondrocytes vascular endothelial cells and immune cells and will also inhibit the expression of the pro-inflammatory factor IL-6 Glucose solution below 3 will not have the effect of inducing apoptosis on cells We believe that the therapeutic effect of 25 hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically Therefore in this study we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution The joint pain level assessment of different types of patients OA and RA before dextrose prolotherapy preliminary period 1 month after treatment midterm period and 3 months after treatment late period will be collected and joint effusion will be measured Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid
We hope that through this study we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions
We hope that through this study we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions
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