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Clinical Trials in Taiwan / NCT07819968
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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

NCT07819968 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-15

Condition(s) studied

Chronic Patellar Tendinopathy

Investigational drug(s) / intervention(s)

Extracorporeal Shock Wave TherapyHyaluronic Acid (HA) →Platelet-Rich Plasma →Normal Saline

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 (

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

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: 1. Typical anterior knee pain ≥3 months (chronic stage) Pain location is concentrated at the lower or upper end of the patellar tendon Pain is aggravated by jumping, changing direction, sprinting, squat jumps, or weight-bearing knee extension movements 2. Typical positive results on physical examination (at least two of the following must be positive): Positive Decline squat test Single-leg decline squat pain ≥3/10 Palpation tenderness over patellar tendon (tenderness ≥3/10) Pain induced by Hop test / drop jump 3. Ultrasound imaging meets the criteria for chronic patellar tendinitis (at least two of the following imaging features must be present): Patellar tendon thickness \>4.0 mm or thicker than the healthy side by ≥15% Hypoechoic area Disorganized fibers Doppler grade 1-2 neovascularity (5) Able to cooperate with research tracking and functional testing Exclusion Criteria: 1. Calcified tendinopathy 2. Acute patellar tendon rupture, partial rupture, or post-operative condition 3. Received other injectable treatments or high-energy laser/shockwave therapy within the past six months 4. Systemic diseases including: autoimmune diseases (e.g., RA, AS), neuromuscular diseases, poorly controlled diabetes (HbA1c \> 8.5%), blood disorders or currently using anticoagulants (unable to safely receive PRP or injections), infectious diseases

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City Kaohsiung

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07819968 on ClinicalTrials.gov ↗ ← All trials in Taiwan