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临床试验/NCT03781349
NCT03781349已完成不适用

Comparative Efficacy on Pain of Two Non-pharmacological Treatments (TENS or MENS) in Patients With Partial Rotator Cuff Tears. A Randomized Trial

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年3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
42
试验地点
2
主要终点
Pain intensity: NRS

研究概览

简要总结

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

详细描述

The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a secondary feature, leading to further disability.

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering shoulder pain because of partial thickness rotator cuff tear, confirmed with MRI and ultrasound scanning.
  • Patients not receiving any recent pharmacotherapy with NSAIDs during the last month, or surgery at the shoulder area at any time point,
  • The referral orthopedic had suggested physiotherapy.

排除标准

  • Patients with open wounds or skin diseases in the shoulder area
  • pregnant women
  • patients with any type of neoplastic disease
  • patients with pacemakers or serious cardiovascular diseases including arrhythmia, - patients with collagen diseases
  • history of shoulder surgery

结局指标

主要结局

Pain intensity: NRS

时间窗: up to 3 months after intervention

Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity

Disability

时间窗: up to 3 months after intervention

SPADI questionnaire (shoulder pain and disability questionnaire). It measures pain and disability caused by shoulder diseases, each question ranging between 0 and 10 (with 0 indicating no disability and 10 indicating worst disability). It includes 5 questions about pain and 8 questions about disability.

次要结局

  • quality of patients' life: EQ 5D(up to 3 months after intervention)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chrysanthi Batistaki

Assistant Professor of Anesthesiology

Attikon Hospital

研究点 (2)

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相似试验

TENS of MENS for Rotator Cuff Tear | 临床试验