Clinical trial NCT06301958: Dextrose Prolotherapy on Articular Cartilage
Official title: The Effects and Molecular Mechanisms of Dextrose Prolotherapy on Articular Cartilage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Knee
Keywords: Dextrose
Prolotherapy
Joint Pain
Synovial Fluid
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, 1 month after treatment, and 3 months after treatment
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: baseline, 1 month after treatment, and 3 months after treatment
measure: Interleukin 6 (IL-6)
timeFrame: baseline, 1 month after treatment, and 3 months after treatment
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital, Chiayi
state: 嘉義市
Study officials:
affiliation: Chang Gung Memorial Hospital, Chiayi
name: Hung-Chih Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References: