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临床试验/NCT00888225
NCT00888225已完成不适用

Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect

Uppsala University4 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2003年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
205
试验地点
4
主要终点
Pain during dynamic and static muscle load

研究概览

简要总结

Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested.

详细描述

Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. It is a common condition in the general population and often results in long-term sick-leave. The etiology is unknown. A large number of treatments have been tried but none is generally accepted. However, in Achilles tendinitis a new treatment has been shown effective. It consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). The latter is currently the most common treatment method.

This project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In addition, blood specimens for a number of neural peptides have been sampled. Moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (PET) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. The health economy of the two treatments will be investigated using data from this project and from available registers.

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 (Participant)

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

  • Verified tennis elbow for more than three months
  • Age 20-75 years
  • Informed consent

排除标准

  • Inability to understand or follow instructions
  • Inability to read or fill in questionnaires
  • Inability to participate at measurement sessions
  • Supinator syndrome
  • Compartment syndrome of anconeus muscle
  • Rhizopathy of arm
  • Inflammatory joint or soft tissue disease including fibromyalgia
  • Previous surgery because of tennis elbow

结局指标

主要结局

Pain during dynamic and static muscle load

时间窗: Month 0, 1, 2, 3, 6, 12

次要结局

  • Muscle strength and function(Month 0, 1, 2, 3, 6, 12)

研究者

发起方
Uppsala University
申办方类型
Other

研究点 (4)

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