跳至主要内容
临床试验/CTRI/2023/02/049731
CTRI/2023/02/049731尚未招募不适用

To study effectiveness of Neuromuscular electrical stimulation in reversibility of fatty infiltration and muscle atrophy in chronic retracted Supraspintus tears

PGIMER CHANDIGARH1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年2月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
To see percentage improvement in fatty infiltration using Goutallier’s staging system and muscle atrophy

研究概览

简要总结

A Prospective Study to see effectiveness of Neuromuscular Electrical Stimulation in reversibility of fatty infiltration and muscle atrophy seen in chronic retracted Supraspinatus tears either due to traumtic or degenerative etiology in skeletally mature patients aged 18-75 years.

The primary objective is to see improvement in fatty infiltration using Goutallier’s staging system and muscle atrophy by Thomazeu’s grading system using Occupation ratio on day 30.

The Secondary Objective is to see clinical improvement following Electrical Stimulation in terms of Visual Analogue Score (VAS) , active range of motion (ROM) , Shoilder pain and Disability index (SPADI) and Constant Score on day 10 and day 30.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Skeletally mature adults of either sex, aged 18 to 75 years with chronic retracted SS tears with fatty infiltration( gd > 1 , according to Goutallier classification or Fusch’s modification of Goutelliar grading based on MRI) of either degenerative or traumatic etiology.

排除标准

  • Arthritis of shoulder joint (osteoarthritis, rheumatoid, arthritis, rotator cuff arthropathy)
  • Brachial plexus injury or any nerve involvement of upper limb like stroke
  • Frozen shoulder following trauma or shoulder surgeries, metabolic conditions (excluding diabetes with controlled sugars who were included), stroke or myocardial infarction
  • Patients who underwent arthroscopic repair for rotator cuff tears on same side
  • Patient who withholds consent.
  • Any patient who cannot provide the necessary data due to any disability.

结局指标

主要结局

To see percentage improvement in fatty infiltration using Goutallier’s staging system and muscle atrophy

时间窗: To see Improvement in Muscle growth and reduction in fatty content by DAY 30

by Thomazeu’s grading system using occupation ratio in chronic retracted Supraspinatus tears following

时间窗: To see Improvement in Muscle growth and reduction in fatty content by DAY 30

Neuromuscular electrical stimulation.

时间窗: To see Improvement in Muscle growth and reduction in fatty content by DAY 30

次要结局

  • 1. To see clinical improvement following Nuromuscular Electrical Stimulation in patients with chronic retracted Supraspintus tears in terms of Visual Analogue score(VAS) .(2.To see clinical improvement following Neuromuscular Electrical Stimulation (NMES) in patients with chronic Supraspintus tears in terms of Active ROM , Shoulder Pain and Diasability Index (SPADI) and Constant Score)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验