Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- rated-tennis-elbow-questionnaire for hand function assessment
研究概览
简要总结
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain.
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding hand function.
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- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding grip strength.
详细描述
Lateral epicondylitis, also known as "tennis elbow", is a common disease present in clinical practice. It affects 1% to 3% in the general population which can reach up to 29% in certain occupations with repetitive wrist movements. It can cause a significant functional decline with a great psychological and economic impact.
Major symptoms include decreased grip and upper-extremity strength along with pain and inflammation originating from the lateral elbow. The pathogenesis of lateral epicondylitis is still controversial, but it is known that not only the tendon of the extensor carpi radialis brevis (ECRB) muscle but also the annular ligament, lateral capsule, radial nerve and some bands of the extensor digitorum communis muscle are involved.
It was originally thought that the cause of lateral epicondylitis was an inflammatory process, which would then result in the symptoms. However, histological studies have demonstrated that, through repetitive injuries at this site, there is a degenerative process and a failure of repair in the ECRB tendon. This is more pronounced than inflammation in other structures.
A variety of therapeutic techniques have been proposed for the appropriate management of patients with lateral elbow tendinopathy including exercise, orthotics, manual therapy, passive modalities, acupuncture or a combination of them.
However, the effectiveness of each treatment option remains debatable. Extracorporeal shockwave therapy (ESWT) is a popular method in the management of common tendinopathies and has been proposed as an effective supplement to other non-invasive therapies. There are two types of extracorporeal shockwave therapy: focused shockwave therapy (FSWT) and radial shockwave therapy (RSWT). Waves that are generated for focused and radial ESWT have very different physical characteristics.
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
- None
盲法说明
Randomization using envelop
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age between 18 - 55 years old.
- •BMI < 35
- •Males and Females
- •Painful chronic tennis elbow during at least 3 previous months identified by positive Mill"s, Maudsley"s and Cozen"s tests.
- •Painful palpation of the lateral epicondyle.
- •Painful resisted middle finger and wrist extension (Maudsley's test).
排除标准
- •Local infection.
- •Malignancy.
- •Elbow arthritis or instability.
- •Pronator-Teres syndrome.
- •Generalized polyarthritis.
- •Neurological disorders (Stroke and Parkinson"s disease).
- •Radial-nerve entrapment.
- •Physical therapy and/or a corticosteroid injection administered within the previous six weeks.
- •Pregnancy.
结局指标
主要结局
rated-tennis-elbow-questionnaire for hand function assessment
时间窗: 3 months
score from that questionnaire Pain Subscale - Add up 5 items. Best score = 0; Worst score = 50 Specific Activities - Add up 6 items Best Score = 0; Worst Score = 60 Usual Activities - Add up 4 items items Best Score = 0; Worst Score = 40 Function Subscale - (Specific Activities + Usual Activities) /2 Best score = 0; Worst score = 50 Total Score = Pain Subscale + Function Subscale Best Score = 0; Worst Score = 100 (pain and disability contribute equally to score)
Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101
时间窗: 3 months
Device used to test the hand grib strength
Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment.
时间窗: 3 months
amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain
次要结局
- Cozen's Test(Before the study for patient selection)
- Maudsley's test(Before the study for patient selection)
- For patient selection Mill's Test(Before the study for patient selection)
研究者
Mennallah Ahmed Mohamed Anwar Elgendy
Principal investigator
Cairo University