Dextrose Prolotherapy on Articular Cartilage

Arthritis Knee Clinical Trial

Official title:

The Effects and Molecular Mechanisms of Dextrose Prolotherapy on Articular Cartilage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301958
• Other study ID #: 202102567A3
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Chang Gung Memorial Hospital
• Contact: Hung-Chih Hsu, PhD
• Phone: +886-3-3621000
• Email: dr.tonyhsu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Willing to sign a written consent form

• Adult men and women with arthritis

Exclusion Criteria:

• Pregnant or lactating women

• Septic arthritis

• Those who have undergone joint surgery within 30 days

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee

Intervention

Drug:
• Dextrose prolotherapy
A 25% dextrose solution is used to relieve arthritis of the knee joint like osteoarthritis and rheumatoid arthritis.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Chiayi	Chiayi City	???

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Measurement of knee pain	baseline, 1 month after treatment, and 3 months after treatment
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Osteoarthritis Index	baseline, 1 month after treatment, and 3 months after treatment
Secondary	Interleukin 6 (IL-6)	An inflammation-related biomarker	baseline, 1 month after treatment, and 3 months after treatment