A Comparative Study Between Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Degree of pain.
研究概览
简要总结
The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis
详细描述
Lateral epicondylitis (LE), or tennis elbow, is the most common elbow pain condition. Pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis [ECRB] and extensor digitorum communis [EDC]), is the most consistent symptom. It affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm.
Transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. We were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. Therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.
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
- •Age from 18-65 years.
- •Both sexes.
- •Symptomatic lateral epicondylitis for more than 6 months.
- •Lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams:
- •Palpation of the lateral epicondyle.
- •Resisted wrist extension (Thompson test).
- •Chair test. With the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg.
排除标准
- •Severe systemic diseases (diabetes or rheumatoid arthritis).
- •Cervical radiculopathy.
- •Major trauma or prior surgery in the tendon of the elbow.
- •Morbid obese patients (body mass index (BMI) of >35 kg/m2).
- •Infection at site of injection.
- •Bleeding diathesis and coagulopathy.
- •Patients who didn't consent to completing visual analog scale , rated tennis elbow evaluation (PRTEE), disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. and refuse to participate in the study.
研究组 & 干预措施
Transcutaneous pulsed radiofrequency group
Patients underwent transcutaneous pulsed radiofrequency at the affected elbow.
干预措施: Transcutaneous pulsed radiofrequency (Device)
Control group
Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions.
干预措施: Methylprednisolone and mepacaine (Drug)
结局指标
主要结局
Degree of pain.
时间窗: 12 weeks after treatment
Assessment of pain severity by visual analog scale (VAS) before treatment and at 2, 4, 8, and 12 weeks after treatment. The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."
次要结局
- Forearm pain(12 weeks after treatment)
- Functional disability(12 weeks after treatment)
- Patient capability(12 weeks after treatment)
研究者
Ahmed Magdy Ahmed Elgazzar
Resident of Anesthesiology,Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University