Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference of two points in pain recorded on the VAS
研究概览
简要总结
Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.
详细描述
Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age range from 18 to 75 years
- •clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months
- •intensity of pain of more than 5 on the Visual Analogue Scale (VAS) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test)
- •the failure of conservative treatments previously made
- •a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study
- •capability of filling in the questionnaires and signing the consent form
排除标准
- •Previous treatment with Cryo-US, ultrasound therapy, ESWT
- •The conjoint presence of bilateral or lateral and medial epicondylitis
- •Acute infection of the soft tissues or the bones adjacent to the area of treatment
- •Local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs
- •Pacemaker, pregnancy
- •Neoplastic disease
- •Raynaud's disease, altered thermal and pain sensitivity, or cold intolerance
- •Evidence of elbow bursitis, or articular or synovial pathologies; signs of elbow laxity or instability
- •Cervicobrachialgia; syndrome of ulnar, radial, or posterior interosseous nerve entrapment
结局指标
主要结局
Difference of two points in pain recorded on the VAS
时间窗: 3, 6, or 12 months after the end of treatments
a difference of two points in pain recorded on the VAS during a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test), between the ESWT Group and the Cryo-US Group, in at least one of the periods taken into account.
次要结局
- Patients satisfaction based on the Roles and Maudsley score(3, 6, or 12 months after the end of treatments)
研究者
Mario Vetrano, MD
MD
University of Roma La Sapienza