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临床试验/NCT01992627
NCT01992627Unknown不适用

A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis

CM Chungmu Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
DASH as the measure of efficacy for HILT

研究概览

简要总结

This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of elbow epicondylosis

详细描述

The diagnosed patients with epicondylosis will be treated with HILTERAPIA HIRO 3.O for a total of four sessions during the entire duration of the treatment protocol. Parameters to be evaluated are tenderness, pain upon active resistive motion and DASH scores. After every treatment session of HILTERAPIA HIRO 3.O, these said parameters will be recorded initially on the first treatment, one week after the initial treatment, two weeks after the initial treatment and four weeks after the initial treatment. Patient is advised to follow-up on the 6th and 12 month post initial HILTERAPIA HIRO 3.O treatment for the reevaluation of the parameters. Tenderness is described as pain upon palpation and is further categorized into, 0= no tenderness, 1 = mild tenderness, 2 = tenderness evident on facial expression and 3 = patient screams upon palpation. Pain is also noted upon active resistive motion of extension/flexion, supination/pronation. Classification includes; 0 = no pain and 1 = mild pain with full power, 2 = severe pain with full power, and 3 = muscle weakness with pain. And for functional scoring will be using the DASH which is a multidimensional disease specific, brief, self-administered measure of symptoms and functional status among subjects with upper limb disorders. The DASH consists of a 30-item questionnaire with 5 response options for each item with a scale ranging from 0, which indicates "least disability," to 100, which indicates "most disability." A change in 12.7 DASH score points is considered to represent clinically significant functional improvement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of medial and lateral elbow pain for at least three months in duration
  • local tenderness for at least three months in duration
  • pain on the epicondyle upon active resistive flexion (medial) and extension (lateral) of the wrist

排除标准

  • previous elbow conservative managements such as physical therapy and elbow injection-based therapies
  • previous surgical management of the elbow

结局指标

主要结局

DASH as the measure of efficacy for HILT

时间窗: On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment

The DASH is intended to measure how much difficulty a subject has when performing common functional tasks and activities. The DASH consists of a 30-item questionnaire with 5 response options for each item with a scale ranging from 0, which indicates "least disability," to 100, which indicates "most disability." It incorporates questions related to functional limitations, symptoms, and psychosocial problems. The DASH has been well validated and has a smaller standard error of measurement and a validity comparable to that of joint-specific measures. A change in 12.7 DASH score points is considered to represent clinically significant functional improvement.

次要结局

  • Pain upon active resistive motion as the measurement of efficacy for HILT(On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment)
  • Tenderness as the measure of efficacy for HILT(On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment)

研究者

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

Sang-Hoon Lhee

Director of CM Chungmu Hospital

CM Chungmu Hospital

研究点 (2)

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