Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Patient-rated Tennis Elbow Evaluation (PRTEE)
研究概览
简要总结
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
详细描述
Patients with elbow epicondylitis will be included in a double-blind, randomized controlled trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP (low leukocyte PRP), one group of patients will be treated with an echo-guided injection of LR-PRP (high leukocyte PRP), and another group of patients will be treated with an echo-guided injection of saline.All enrolled patients undergo sampling of a venous whole blood bag of approximately 300 cc from which Fresh Autologous PRP (PRP-A) will subsequently be obtained. According to randomization, a "leukodepletion" filter will be used to remove leukocytes in order to obtain LP-PRP. Instead, an aliquot of PRP will be cryopreserved and made available for the patient for a possible second PRP infiltration if there is no benefit after 6 months after the first infiltration.The patient will then be placed on the randomization list and will, therefore, be assigned to one of the three treatment groups (leukocyte-rich PRP, leukocyte-poor PRP, or saline solution). In the case of patients in the saline injection group, PRP will be prepared with or without leukocytes according to a dedicated randomization list, for possible treatment after 6 months if necessary.The patient will subsequently undergo 1 echo-guided infiltration, according to randomization.Patients will be clinically evaluated before the infiltration procedure and at 1-3-6-12 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checkups during follow-up. Any adverse events to treatment will also be evaluated during follow-up visits. The duration and extent of swelling and pain following infiltration will be reported, and any drug therapies given by the patient will be recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
They will be "blinded" patients, health professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
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
- •Patients with epicondylitis of the elbow:
- •Patients with clinical picture of epicondylitis;
- •Duration of symptoms > 3 months
- •Ultrasound picture of short or long radial extensor carpal tendinopathy;
- •Age > 18 and < 65
- •Both sexes;
- •Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
- •Hemoglobin > 11 g/dl;
- •Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- •Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- •No clinically significant electrocardiographic changes (Recently performed ECG);
- •Ability and consent of the patient to actively participate in clinical follow-up;
- •Signature of informed consent.
排除标准
- •Patients undergoing previous surgical treatment on the epicondylar tendons;
- •Patients undergoing epicondylar infiltration in the previous 6 months;
- •Inability of patients to actively participate in clinical follow-up;
- •Incapacitated patients;
- •Patients with states of immunodepression;
- •Patients with fibromyalgia;
- •Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
- •Patients with uncontrolled thyroid metabolic disorders;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Patients who have taken NSAIDs in the 3 days prior to blood collection;
- •Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
- •Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
- •Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- •Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
研究组 & 干预措施
Leukocyte-rich Platelet rich plasma (LR-PRP)
This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
干预措施: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) (Biological)
Leukocyte-poor Platelet rich plasma (LP-PRP)
This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
干预措施: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP) (Biological)
Saline solution
This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.
干预措施: Placebo (saline solution) (Drug)
结局指标
主要结局
Patient-rated Tennis Elbow Evaluation (PRTEE)
时间窗: 6 months follow-up
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100.
次要结局
- EuroQol Visual Analogue Scale (EQ-VAS)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Disability of the arm, shoulder and hand score (DASH)(baseline, 1 month, 3 months, 6 months and 12 months follow-up)
- Expectations of treatment efficacy(baseline)
- Visual Analogue Scale (VAS)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Oxford Elbow Score (OES)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Final treatment opinion(1 month, 3 months, 6 and 12 months follow-up)
- Effectiveness of the blinding procedure(baseline)
- Patient-rated Tennis Elbow Evaluation (PRTEE)(baseline, 1 month, 3 months and 12 months follow-up)
- Tegner Activity Level Scale(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Pain detect(baseline)
- Patient Acceptable Symptom State (PASS)(baseline, 1 month, 3 months, 6 and 12 months follow-up)