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临床试验/NCT05260125
NCT05260125招募中4 期

Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
50
试验地点
1
主要终点
Shoulder Range of Motion

研究概览

简要总结

The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.

详细描述

Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study.

Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value > 3 during passive shoulder joint movement will be included in the study.

Exclusion criteria from the study will be determined as mini mental test score < 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents.

It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex.

Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block.

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 (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having hemiplegic shoulder pain for 3 months
  • Visual analogue scale score > 3 during passive shoulder joint movement on the hemiplegic side

排除标准

  • Mini mental test score <24
  • Patients with uncontrolled diabetes, coagulopathy
  • Botulinum toxin administration in the past six months,
  • Any injection in the shoulder region in the last six months
  • Having hypersensitivity to injection agents

研究组 & 干预措施

Ultrasound-guided Suprascapular Nerve Block

Experimental

Ultrasound-guided Suprascapular Nerve Block

干预措施: Ultrasound-guided Suprascapular Nerve Block (Drug)

Anatomical Landmark-guided Suprascapular Nerve Block

Active Comparator

Anatomical Landmark-guided Suprascapular Nerve Block

干预措施: Anatomical Landmark-guided Suprascapular Nerve Block (Drug)

结局指标

主要结局

Shoulder Range of Motion

时间窗: 12 week after suprascapular nerve block

The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

Visual Analogue Scale

时间窗: 12 week after suprascapular nerve block

Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

次要结局

  • Barthel Index(12 week after suprascapular nerve block)
  • Modified Ashworth Scale(12 week after suprascapular nerve block)
  • Brunnstrom Stages of Stroke Recovery(12 week after suprascapular nerve block)
  • The Beck Depression Inventory(12 week after suprascapular nerve block)

研究者

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

Serdar Kilinc

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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