Comparison Of Ultrasound-guided Dry Needling and Platelet-rich Plasma Administration in the Treatment of Refractory Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- visual analog scale
研究概览
简要总结
This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not responded to at least six weeks of conservative treatment were included. Exclusion criteria included cervical disc disease, nerve entrapment, arthrosis, uncontrolled metabolic disorders, bleeding disorders, prior elbow surgery or injection, pregnancy, cognitive impairment, or compromised skin at the injection site. A G*Power sample size calculation determined that at least 50 patients were needed.
Participants were randomly assigned to two groups: 25 received ultrasound-guided dry needling and 25 received platelet-rich plasma (PRP) injections. All participants gave informed consent, and the study adhered to the Declaration of Helsinki. Baseline demographic and clinical data were collected, and the diagnosis was confirmed using Mills, Maudsley, and Thomsen tests, along with grip-strength assessment. Pain and function were evaluated using the PRTEE, Visual Analog Scale (VAS), and QuickDASH questionnaires at baseline, and at 1, 3, and 6 months post-treatment.
Ultrasound imaging was used to identify tendinopathic changes. Local anesthesia was administered with 2 mL of prilocaine.
In the dry needling group, an 18-gauge needle was used to fenestrate the tendon with 40-50 passes in a "peppering" motion under continuous ultrasound guidance.
In the PRP group, 15 mL of blood was drawn, centrifuged, and approximately 2 mL of PRP was injected into the lesion under ultrasound guidance.
After the procedure, patients were advised to apply ice, perform passive stretching, avoid lifting heavy objects, and refrain from NSAID use for two weeks. Gradual return to normal activities was encouraged thereafter to restore full elbow function.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and 65 years of age, having a clinical diagnosis of lateral epicondylitis based on localized lateral elbow pain exacerbated by resisted wrist or middle finger extension and tenderness over the lateral epicondyle on physical examination, and failure to respond to at least six weeks of conservative treatment.
排除标准
- •the presence of cervical discopathy or upper extremity nerve entrapment, radiocapitellar arthrosis, uncontrolled metabolic diseases (hypothyroidism, diabetes), bleeding diathesis, a history of previous elbow injection or surgery, pregnancy or lactation, cognitive impairment, and skin compromise at the injection site
研究组 & 干预措施
dry needle
An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes.
干预措施: dry needle (Procedure)
platelet rich plasma injection
A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance.
干预措施: Platelet Rich Plasma (Procedure)
结局指标
主要结局
visual analog scale
时间窗: 1-3-6 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire
时间窗: 1-3-6 months
Patient-Rated Tennis Elbow Evaluation
时间窗: 1-3-6 months
次要结局
未报告次要终点
研究者
Yusuf Kıratlıoğlu
Ankara University
Ankara University
