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COMPLETED
NCT07819955
NA

Comparison of the Pain and Functional Improvement of Combined Extracorporeal Shockwave Therapy With or Without Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injection on Advanced Osteoarthritis of the Knees.

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

This was a single group, double-blind, randomized clinical trial that enrolled 48 patients with Kellgren-Lawrence grade II to IV osteoarthritis of the knee. Patients were randomly assigned to three groups: Saline + ESWT (S+E group), High Platelet-Rich Plasma (PRP + ESWT (P+E group), and Hyaluronic Acid + ESWT (HA + ESWT (H+E group). All patients were followed for one year. Assessments included the Visual Analogue Scale (VAS), serum enzyme-linked immunosorbent assay (ELISA), knee X-ray and ultrasound examinations, and functional scores (WOMAC, KOOS, and IKDC).

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-08-04

Completion Date

2025-06-27

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DEVICE

Extracorporeal Shock Wave Therapy

Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive, injection-free, and radiation-free treatment method commonly used to treat musculoskeletal disorders. Compared to conventional instrument-based treatments, it can reach deeper tissues. Shock waves can cause microscopic damage to injured or poorly healed tissues, promoting tissue repair, angiogenesis, and pain relief. Using a Storz Medical shockwave therapy machine at an energy of 0.25 mJ/mm², 4000 shocks were administered each time, followed by three treatments at two-week intervals.

DRUG

Normal Saline

Physiological saline solution is a mixture of sodium chloride (salt) and water, with a concentration of 0.9%, and its osmotic pressure is equal to that of human body fluids. Because sterile physiological saline solution has a simple composition and its osmotic pressure is similar to that of the human body and it has no pharmacological activity, it is often used as a sham treatment control group.

DRUG

Hyaluronic Acid (HA)

Hyaluronic acid (also known as hyaluronic acid) is a biological polysaccharide with high water absorption and viscoelasticity. It is a component of the articular cartilage matrix and one of the main components of joint lubricating fluid. Hyaluronic acid in the joint cavity can help joints move smoothly, cushion impacts, and reduce wear and tear between articular cartilage.

BIOLOGICAL

Platelet-Rich Plasma

PRP therapy mainly involves drawing the patient's own blood, centrifuging it at high speed through a special extraction tube to separate platelets, and then injecting the concentrated platelets into the joint cavity. Utilizing the repair and regeneration capabilities of the growth factors abundant in the platelet vesicles, it repairs the worn-out meniscus cartilage, promotes tissue regeneration, and relieves the pain of degenerative knee osteoarthritis.

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan