Effects of Adding Platelet-Rich Plasma (PRP) Therapy to Extracorporeal Shock Wave Therapy (ESWT) in Patients With Lateral Epicondylitis: Double-Blind Randomized Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week
研究概览
简要总结
The aim of this study is to determine the effectiveness of adding PRP or Sham PRP injection to ESWT treatment in patients with lateral epicondylitis on pain, muscle strength, functional activities, quality of life and work activities, and to determine the superiority of the treatments over each other.
详细描述
Lateral epicondylitis (LE) is one of the most common elbow problems. It is characterized by pain in the lateral epicondyle of the humerus and on the surface of the extensor muscles of the forearm. It is seen in those who perform activities involving repetitive forced wrist extension and can lead to chronic pain syndrome.
Various treatment methods are used in the treatment of LE in order to reduce the patient's pain and increase his/her functional capacity. There are more than 40 treatment methods in the literature such as oral and local non-steroidal anti-inflammatory drugs (NSAID), cold application, deep friction massage, stretching and strengthening exercises, ultrasound, laser, ESWT, corticosteroid/botulinum toxin/glucosamine/autologous blood/platelet rich plasma (PRP) injections, prolotherapy, acupuncture, manipulation, and surgery.
Extracorporeal shock wave therapy (ESWT) is a method that aims to provide treatment by focusing high amplitude sound waves on the area of the body to be applied.
PRP is an autologous concentration of human platelets in a small volume of plasma produced by centrifuging a patient's own blood.
This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 3 groups: ESWT + therapeutic exercise, ESWT + Sham PRP injection + therapeutic exercise, ESWT + PRP injection + therapeutic exercise.
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 (Investigator, Outcomes Assessor)
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
- •Diagnosed with lateral epicondylitis after physical examination
- •No other pathology detected on direct radiography
- •Complaints persisting for more than 3 months despite the application of other conservative treatment methods
- •Patients accepting to give blood for PRP or sham injection and can tolerate elbow injection and extracorporeal shock wave therapy (ESWT)
排除标准
- •Not being able to fully cooperate with the study and inability to read and write,
- •Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months,
- •Previous surgery or ESWT treatment in the area to be treated,
- •Pregnant women,
- •Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies),
- •Those who have a history of direct trauma to the elbow and a history of fracture,
- •Those with a history of malignancy,
- •Bleeding diathesis,
- •Complex regional pain syndrome,
- •Presence of acute systemic infection,
- •Presence of local infection at the injection site,
- •Peripheral vasculopathy,
- •Cervical radiculopathy,
- •Patients with contraindications to ESWT application (pregnancy, cancer, coagulation disorders, inflammatory disease, pacemaker, metal implant in the area to be applied) were excluded from the study.
结局指标
主要结局
Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week
时间窗: baseline and 12th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. The patient will be asked to score rest, movement, and nighttime pain.
次要结局
- Change from baseline Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) at 4th and 12th week(baseline and 12th week)
- Change from baseline Ultrasonographic examination at 4th and 12th weeks(baseline and 12th week)
- Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks(baseline and 12th week)
- Change from baseline Handgrip strength at 4th and 12th week(baseline and 12th week)
- Change from baseline quality of life (Short Form 36 (SF-36)) at 4th and 12th weeks(baseline and 12th week)
研究者
Ali İzzet Akçin
Principal Investigator-Research Assistant-MD
Afyonkarahisar Health Sciences University