Dextrose Prolotherapy on Articular Cartilage

NCT06301958 | Recruiting

• 1 other identifier: 202102567A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee

Keywords

Dextrose; Prolotherapy; Joint Pain; Synovial Fluid

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  Measurement of knee pain

  baseline, 1 month after treatment, and 3 months after treatment

Secondary Outcomes (2)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  baseline, 1 month after treatment, and 3 months after treatment

• Interleukin 6 (IL-6)

  baseline, 1 month after treatment, and 3 months after treatment

Study Arms (1)

Dextrose prolotherapy

EXPERIMENTAL

A subject received a single intra-articular injection of 25% hypertonic glucose solution 10 mL (1:1 of 50% dextrose and normal saline) into one knee with arthritis after aspiration of all synovial fluid.

Drug: Dextrose prolotherapy

Interventions

Dextrose prolotherapy DRUG

A 25% dextrose solution is used to relieve arthritis of the knee joint like osteoarthritis and rheumatoid arthritis.

Also known as: Regenerative injection therapy

Dextrose prolotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign a written consent form
• Adult men and women with arthritis

You may not qualify if:

• Pregnant or lactating women
• Septic arthritis
• Those who have undergone joint surgery within 30 days

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Chiayi

Chiayi City, 嘉義市, 600, Taiwan

RECRUITING

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hung-Chih Hsu, PhD

  Chang Gung Memorial Hospital, Chiayi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chih Hsu, PhD

CONTACT

+886-3-3621000; dr.tonyhsu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: January 21, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)