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临床试验/CTRI/2018/03/012824
CTRI/2018/03/012824招募中4 期

Ultrasonographic Evaluation of Radial Neuropathy in Patients with Lateral Epicondylitis and its Correlation with Pain and Functional Outcome Before and After Corticosteroid Injection into the Extensor Tendon

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年5月20日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
1. To compare effect of a single dose ultrasound guided corticosteroid injection with conservative treatment on pain and function using quick-DASH in patients with lateral epicondylitis.

研究概览

简要总结

Lateral epicondylitis is a common painful condition around the elbow which continues to perplex both the patient and practitioner due to inconsistent treatment options and outcomes. Although many non-operative and surgical options exist, there remains a general lack of consensus regarding optimal treatment. Corticosteroids are commonly used to treat lateral epicondylitis,however, the way in which they work is currently unknown. Findings of this study will evaluate the effect of steroid with conservative treatment on pain and functional outcome. Ultrasonographic evaluation of the radial nerve may support previous literature that some of the chronic complaints of these patients might actually be due to radial nerve entrapment. The hypothesis of the study is as follows : Single dose of ultrasound guided corticosteroid injection in the extensor tendon and conservative treatment shows no change on ultrasonographic measurement of the cross-sectional area of the radial nerve at the elbow and in the spiral groove in patients with lateral epiconylitis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinical Diagnosis of Lateral epicondylitis.

排除标准

  • Subjects with history of previous treatment for ipsilateral lateral epicondylitis, other elbow pathologies, cervical vertebrae/upper limb disorders, previous elbow surgery, joint limitations due to a previous radius/ulna fracture, osteoporosis, malignancy, hemophilia
  • Any clinical finding suggestive of peripheral nerve (ulnar, radial, median)
  • Mechanical symptoms ( locking, clicking, limited motion) of elbow including joint limitations following radius/ulna fracture 4.Local infection at site of injection or generalized infection
  • Refusal to participate in the study
  • Prior steroid injection in same elbow
  • Known allergy to steroid
  • History of trauma around elbow
  • Contraindication of steroid ( Uncontrolled Hypertension, Diabetes mellitus, Pregnancy)
  • Bilateral lateral epicondylitis.

结局指标

主要结局

1. To compare effect of a single dose ultrasound guided corticosteroid injection with conservative treatment on pain and function using quick-DASH in patients with lateral epicondylitis.

时间窗: 0, 4 and 12 weeks

2. To compare effect of single dose ultrasound guided corticosteroid injection with conservative treatment on ultrasonographic measurement of the cross-sectional area of the radial nerve in patients with lateral epicondylitis

时间窗: 0, 4 and 12 weeks

次要结局

  • 1. To compare ultrasonographic measurement of cross-sectional area of the radial nerve before and after single dose ultrasound guided corticosteroid injection in patients with lateral epicondylitis ( on the affected and unaffected sides)(2. To correlate quick-DASH scores with ultrasonographic evaluation of the radial nerve in patients with lateral epicondylitis)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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