跳至主要内容
临床试验/NCT01391000
NCT01391000已完成不适用

Light Amplification by Simulated Emission Radiation Carbon Dioxide (Laser CO2) Versus Transcutaneous Electrical Stimulation (TENS) for the Reduction of Pain in Patients After Reconstruction of the Rotator Cuff. A Randomized Controlled Trial

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Visual Analogue Scale Mean Score

研究概览

简要总结

The purpose of this study is to evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff.

详细描述

To evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff and to evaluate, at the end of the rehabilitation period, the range of motion, the function gained and the quality of life comparatively in the two groups of patients treated with Transcutaneous Electrical Stimulation or Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects after surgery for rotator cuff injury of traumatic and / or degenerative

排除标准

  • concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.

研究组 & 干预措施

Laser CO2

Experimental

干预措施: LASER CO2 (Procedure)

TENS

Active Comparator

干预措施: TENS (Procedure)

结局指标

主要结局

Visual Analogue Scale Mean Score

时间窗: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)

To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.

次要结局

  • Constant Murley Score for Range of Motion and Shoulder Function Assessment.(Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks))
  • Short Form 12-PCS for Quality of Life Assessment(Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验