Dextrose Prolotherapy on Articular Cartilage

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06301958
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Hung-Chih Hsu, PhD
Phone	+886-3-3621000
Email	dr.tonyhsu@gmail.com
Status	Recruiting
Phase	N/A
Start date	January 21, 2023
Completion date	August 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.