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ACTIVE NOT RECRUITING
NCT07819968
NA

Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

Chronic patellar tendinopathy is highly prevalent among youth, amateur, and elite athletes, with rates reaching 30-40% in high-performance populations. Among current conservative treatments, platelet-rich plasma (PRP) injections and extracorporeal shockwave therapy (ESWT) have demonstrated promising clinical outcomes. However, high-quality randomized controlled trials comparing ESWT alone versus ESWT combined with different injection therapies remain lacking. Objective: To compare the clinical effectiveness of ESWT alone, ESWT combined with hyaluronic acid (HA), and ESWT combined with PRP in athletes with chronic patellar tendinopathy. Methods: A three-arm, single-blind randomized controlled trial will be conducted. Athletes participating in sports with repetitive jumping or explosive lower-limb loading will be enrolled and stratified by sport type. Inclusion criteria include typical anterior knee pain, a positive decline squat test, and ultrasonographic evidence of tendon thickening or hypoechoic changes. Calcified tendinopathy will be excluded. Outcomes will be assessed at 1, 3, 6, 9, and 12 months, including VAS, VISA-P, SPORTS scale, sport-specific performance tests (vertical jump, single-leg hop, agility tests), and return-to-play (RTP) time. Expected Impact: This study aims to address three key clinical questions: 1. Is ESWT alone adequate as an initial treatment for chronic patellar tendinopathy in athletes? 2. If adjunctive injection is needed, does HA or PRP provide superior short- and long-term outcomes? 3. Which treatment strategy results in the fastest safe return to sport? The findings of this trial will provide evidence-based guidance for clinicians and contribute to the development of more precise treatment algorithms, ultimately enhancing performance longevity and protecting the careers of high-level athletes.

Official title: Comparative Effectiveness of Extracorporeal Shockwave Therapy Combined With Different Injection Treatments in Athletes With Chronic Patellar Tendinopathy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

15 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-09-01

Completion Date

2028-07-31

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DEVICE

Extracorporeal Shock Wave Therapy

Shockwave therapy is a treatment method that uses high-energy sound waves delivered to body tissues. Through shockwave stimulation of specific frequencies and energy levels, it acts on areas of pain or dysfunction, promoting tissue repair. It is commonly used for chronic musculoskeletal discomfort and sports injury-related problems. In this program, shockwave therapy is the basic treatment, and each experimental group will receiveExtracorporeal Shock Wave Therapy (

DRUG

Hyaluronic Acid (HA)

Hyaluronic acid is primarily used in medicine as an intra-articular injection to relieve pain from osteoarthritis and lubricate joints.

BIOLOGICAL

Platelet-Rich Plasma

PRP (Platelet-Rich Plasma) Brief Introduction and Definition: Concentrated blood plasma rich in platelets and growth factors, extracted from the patient's own blood. Uses: Belonging to regenerative medicine and proliferative therapy, it is commonly used to help repair soft tissues such as muscles, tendons, ligaments, and joints. Principle: Utilizing growth factors from the patient's own blood, it accelerates the healing and regeneration of body tissues.

OTHER

Normal Saline

Normal saline is a 0.9% sterile aqueous solution of sodium chloride. Its osmotic pressure is similar to that of human blood plasma, and it is widely used in medical and daily care. In this study, it was used as a placebo.

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan