Comparative Effectiveness of Extracorporeal Shockwave Therapy Combined With Different Injection Treatments in Athletes With Chronic Patellar Tendinopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale(VAS)
研究概览
简要总结
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:
- Is ESWT alone adequate as an initial treatment for chronic patellar tendinopathy in athletes?
- If adjunctive injection is needed, does HA or PRP provide superior short- and long-term outcomes?
- 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.
详细描述
1. Research Objective: Chronic patellar tendinitis is a common and highly recurrent sports injury among advanced athletes. Currently, various non-surgical treatments, such as ESWT and PRP injections, are commonly used clinically. However, high-quality randomized controlled trials are lacking regarding whether combined injection therapy is necessary and whether ESWT combined with HA or PRP is more suitable for athletes. This study aims to comprehensively compare the efficacy of ESWT alone versus ESWT combined with either injection therapy through three parallel, stratified, randomized, single-blind clinical trials, providing clinically applicable treatment guidelines.
The objectives of this study are:
- To compare the clinical efficacy differences between ESWT alone and ESWT combined with HA/PRP.
- To compare the efficacy differences between ESWT combined with HA and ESWT combined with PRP at different time points.
- To clarify the impact of different treatment strategies on athletes' return to play (RTP).
2. Research Hypotheses:
- ESWT combined with either HA or PRP will be superior to ESWT alone in terms of pain relief (VAS).
- ESWT combined with HA will be more effective than ESWT combined with PRP in short-term pain relief. (3) ESWT combined with PRP is superior to ESWT alone or ESWT+HA in terms of mid- to long-term functional improvement, motor performance, and specific tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
排除标准
- •Calcified tendinopathy
- •Acute patellar tendon rupture, partial rupture, or post-operative condition
- •Received other injectable treatments or high-energy laser/shockwave therapy within the past six months
- •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
研究组 & 干预措施
ESWT+normal saline
This group served as the control group in the experimental design, receiving only shockwave therapy. Saline was administered only for the purpose of a single-blind trial.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+normal saline
This group served as the control group in the experimental design, receiving only shockwave therapy. Saline was administered only for the purpose of a single-blind trial.
干预措施: Normal Saline (Other)
ESWT+hyaluronic acid (HA)
deliver a gel-like fluid directly into the joint to lubricate cartilage and relieve osteoarthritis pain when basic treatments fail.
Hyaluronic acid combined with shockwave therapy aims to achieve effects beyond pain relief.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+hyaluronic acid (HA)
deliver a gel-like fluid directly into the joint to lubricate cartilage and relieve osteoarthritis pain when basic treatments fail.
Hyaluronic acid combined with shockwave therapy aims to achieve effects beyond pain relief.
干预措施: Hyaluronic Acid (HA) (Drug)
ESWT+Pplatelet-rich plasma (PRP)
A platelet-rich plasma (PRP) injection is a treatment that uses a high concentration of your own blood platelets to help heal injured joints, tendons, and muscles.
The combination of PRP and shockwave therapy is expected to achieve results exceeding those of either treatment alone.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+Pplatelet-rich plasma (PRP)
A platelet-rich plasma (PRP) injection is a treatment that uses a high concentration of your own blood platelets to help heal injured joints, tendons, and muscles.
The combination of PRP and shockwave therapy is expected to achieve results exceeding those of either treatment alone.
干预措施: Platelet-Rich Plasma (Biological)
结局指标
主要结局
Visual Analogue Scale(VAS)
时间窗: From enrollment to the end of treatment at 48 weeks
VAS（Visual Analogue Scale）：Ask the patient to mark the degree of their pain on a 10 cm line, from "no pain" on the far left to "unbearable pain" on the far right. The "Numerical Rating Scale" uses a numerical concept of 0-10 points to express the degree of pain, from no pain (0 points) to very painful (10 points).
次要结局
- The Victorian Institute of Sport Assessment (VISA-) Patella (P) Questionnaire(From enrollment to the end of treatment at 48 weeks)
- SPORTS score (Subjective Patient Outcome for Return to Sports)(From enrollment to the end of treatment at 48 weeks)
- Return to Play (RTP)(From enrollment to the end of treatment at 48 weeks)