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临床试验/NCT02700906
NCT02700906已完成不适用

Corticosteroid and Lidocain Injections for Tennis Elbow

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE)

研究概览

简要总结

The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

详细描述

Lateral epicondylitis or tennis elbow is a tendinopathy of the common extensor origin of the lateral elbow, and is estimated to have an annual incidence of 1-3%. It is characterized by tenderness over the lateral epicondyle of the humerus, normal range of motion, and pain on resisted extension of the wrist or fingers. Symptoms can persist for between 6 months and 2 years but usually resolve within 12 months. Although tennis elbow is often self-limited, around 20% of cases are refractory to conservative care. Tennis elbow is now thought to be non-inflammatory, and the pathologies are characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration, and neovascularization.

Treatment of tennis elbow includes relative rest, physical therapy (therapeutic exercise, massage, therapeutic ultrasound, lower power laser, etc.), analgesics, non-steroidal anti-inflammatory drugs, glyceryl trinitrate patches, injection therapy (corticosteroid, hyaluronan gel, botulinum toxin, and autologous platelet-rich plasma), shock wave therapy, and even surgery. Previous studies showed corticosteroid injection is effective in the short term, but is harmful in the long-term, and is more likely to have a recurrence. In consideration of a degenerative lesion in tennis elbow, corticosteroid injection may be not an ideal agent. Although plate-rich plasma injection showed promising results, the high cost limited its widespread clinical use. Since local lidocain injection is commonly used in the management of myofascial pain syndrome, it might be effective in the treatment of tendinopathy like tennis elbow. The purpose of this study is to compare the effect of corticosteroid injection and lidocain injection in the treatment of tennis elbow. The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 20 and 75 years of age, with lateral elbow pain ≥4 in pain VAS for at least 1 month
  • Reproducibility of pain by 2 or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow; resisted wrist extension (dorsiflexion) and pronation with the elbow in extension
  • Pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension.

排除标准

  • not fulfill inclusion criteria

研究组 & 干预措施

Corticosteroid injection

Active Comparator

For corticosteroid injection, triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.

干预措施: Corticosteroid (Drug)

Lidocaine injection

Active Comparator

For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.

干预措施: Lidocaine (Drug)

结局指标

主要结局

change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE)

时间窗: baseline, 2 weeks, 2 months

The primary outcome measure is the change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE), which is a tennis elbow-specific questionnaire evaluating disease-specific quality of life. PRTEE includes a 5-item pain scale, with o indicating no pain and 10 indicating the worst pain imaginable; a 10-item functional disability scale, with 0 indicating no difficulty and 10 indicating greatest difficulty (unable to do). The scores range from 0 (good quality-of- life, no pain or disability) to 100 (poor-quality of-life, extremes pain and disability).

次要结局

  • pain-free grip strength(baseline, 2 weeks, 2 months)
  • ultrasound elbow assessment(baseline, 2 weeks, 2 months)
  • treatment satisfaction(baseline, 2 weeks, 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin-Fen Hsieh

Chief

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (1)

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