Clinical and Morphological Evaluation Following Treatment of Lateral Epicondylar Tendinopathy with PRP or L-PRP,saline- Prospective Randomized Double Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Improvement in Pain (VAS Score)
研究概览
简要总结
Lateral epicondylar tendinopathy (LET), or tennis elbow, is a degenerative condition affecting the forearm's extensor tendons. It commonly leads to pain, reduced grip strength, and impaired function, particularly in individuals performing repetitive wrist and forearm movements. Standard treatments, including physiotherapy, braces, and anti-inflammatory medications, provide relief but do not always lead to full recovery. Platelet-rich plasma (PRP) has gained interest as a regenerative therapy with the potential to enhance tendon healing and improve clinical outcomes.
This randomized, double-blind, placebo-controlled trial aims to evaluate PRP's effectiveness in treating LET, comparing it to leukocyte-rich PRP (L-PRP) and saline (placebo). Additionally, it assesses the composition of PRP and its role in tendon regeneration.
The study will enroll 80 patients diagnosed with LET, meeting predefined clinical criteria. Participants will be randomized into three groups (PRP, L-PRP, saline) and receive two injections (day 0 and day 7). PRP will be prepared using a standardized protocol to ensure consistency.
Patients will undergo clinical evaluations (VAS, Mayo Elbow Score, SECEC Elbow Score), grip strength testing, and MRI scans at baseline and 24 weeks post-treatment. The PRP composition will be analyzed in a laboratory. Follow-ups will be conducted at 12, 24, and 54 weeks to monitor pain reduction, functional improvement, and tendon healing.
This study will provide critical insights into PRP's therapeutic potential, helping refine treatment approaches for LET and improve patient outcomes.
详细描述
Detailed Description
Study Rationale
Lateral epicondylar tendinopathy (LET), commonly referred to as tennis elbow, is a chronic degenerative condition affecting the common extensor tendon (CET) at the lateral epicondyle of the humerus. It is commonly observed in individuals engaged in repetitive wrist and forearm movements, such as athletes, manual laborers, and office workers. The primary pathological mechanism involves microtears leading to pain, reduced grip strength, and impaired function.
Conservative treatments, including physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and bracing, often provide temporary symptom relief but do not facilitate tendon regeneration. Corticosteroid injections may offer short-term pain relief but have been associated with tendon degeneration and higher recurrence rates. Given the limitations of these treatments, platelet-rich plasma (PRP) has emerged as a promising biological therapy due to its high concentration of growth factors that promote tissue healing, angiogenesis, and anti-inflammatory effects.
However, the optimal formulation of PRP remains controversial. Some studies suggest that leukocyte-rich PRP (L-PRP) may enhance the inflammatory response and accelerate healing, while others indicate that leukocyte-poor PRP (LP-PRP) may have superior effects by reducing excessive inflammation. The cellular composition of PRP is not standardized across clinical studies, leading to variability in treatment outcomes. This study seeks to clarify the role of PRP in LET treatment, determine whether L-PRP offers superior benefits, and evaluate its effects on pain relief, functional recovery, and tendon healing over time.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-time diagnosis of chronic lateral epicondylitis with a duration of at least 1 month, age of 18 years or more, and signed informed consent to participate in the study
排除标准
- •pregnancy, any previous treatment for the condition (including injections around the elbow, rehabilitation, or use of orthoses), previous surgical treatment of the elbow, other painful elbow conditions, co-existing upper limb and/or neck pain, prior elbow trauma or arthritic changes, posterior interosseous nerve (PIN) neuropathy, and systemic disorders
研究组 & 干预措施
Standardized PRP Injection
A standardized PRP preparation protocol (without commercial kits) is used, ensuring consistency in platelet concentration.
Preparation Process:
Blood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma PRP Isolation: Pure PRP extracted for injection Injection Procedure: 2 ml of PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis
干预措施: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) (Other)
Standardized leukocyte-rich PRP (L-PRP)
A standardized leukocyte-rich PRP (L-PRP) preparation protocol (without commercial kits) is used to ensure consistency in platelet and leukocyte concentrations.
Preparation Process:
Blood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma L-PRP Isolation: Leukocyte-rich PRP extracted for injection Injection Procedure: 2 ml of L-PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis
干预措施: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) (Other)
Saline Injection (Placebo Control)
A placebo control group receiving a standardized saline injection to evaluate the efficacy of PRP and L-PRP treatments.
Procedure:
Injection of 2 ml of sterile saline into the tendon pain area, following the same protocol as the PRP and L-PRP groups.
干预措施: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) (Other)
结局指标
主要结局
Improvement in Pain (VAS Score)
时间窗: 12 months
Description: This study aims to evaluate whether PRP reduces pain in patients with lateral epicondylar tendinopathy (LET). Assessment Tool: Visual Analog Scale (VAS) Scale: 0 to 10 (0 = no pain, 10 = worst possible pain) Higher scores indicate worse pain outcomes. Time Frame: 12 months
Grip Strength
时间窗: 12 months
Grip Strength: The study includes grip strength testing with isometric grip strenght measure BTE, which is a primary measure of functional improvement following treatment.
Improvement in Functional Outcomes (Oxford Elbow Score - OES)
时间窗: 12 months
Description: This study will assess whether PRP improves elbow function and daily activity performance in LET patients. Assessment Tool: Oxford Elbow Score (OES) Scale: 0 to 48 (0 = worst function/pain, 48 = best function/pain) Higher scores indicate better functional outcomes.
次要结局
未报告次要终点