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临床试验/NCT06545357
NCT06545357已完成不适用

Evaluating the Effectiveness of Treating Shoulder Subluxation After Stroke With Modified Acupuncture of Biceps Brachii Muscle, Supraspinatus Muscle and Deltoid Muscles: a Randomized, Double-blind, Controlled Clinical Trial

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年7月28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
72
试验地点
2
主要终点
The grade of shoulder subluxation was measured according to Hall J's quantitative method

研究概览

简要总结

Stroke is the most common emergency in neurology and is also the leading cause of disability, so recovery of movement after stroke is very important. However, a common complication of stroke is shoulder subluxation, which hinders recovery of movement, thereby leading to shoulder pain and increasing the level of disability after stroke. Neuromuscular electrical stimulation affecting the biceps brachii muscle, supraspinatus muscle and deltoid muscles has been proven to be relatively effective in treating shoulder subluxation after stroke. However, this method does not go through the skin, so it is difficult to have a deep impact on the muscles and difficult to cause selective muscle contractions, so the treatment of this disease is still limited. In traditional medicine, modified acupuncture has a mechanism of action similar to neuromuscular electrical stimulation and is a method that passes through the skin, stimulating muscles effectively and selectively. In our study, we wanted to evaluate the effectiveness of treating shoulder subluxation after stroke with modified acupuncture of biceps brachii muscle, supraspinatus muscle and deltoid muscles

详细描述

Participants and methods: A randomized controlled clinical trial was conducted by comparing the change in shoulder subluxation in post-stroke patients. A total of 72 participants were randomly assigned to 2 groups using GraphPad software on the computer, and the allocation ratio was 1:1. Participants in the intervention group were received modified acupuncture of biceps brachii muscle, supraspinatus muscle and deltoid muscles, while the control group were received conventional electroacupuncture of acupuncture points along The Stomach Channel -Yangming in the shoulder region. The result are the change in the degree of shoulder subluxation according to the qualitative method of Van Langenberghe and Hogan and the quantitative method of Hall J. This study was conducted randomized, controlled and double-blind.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients satisfy all of the following criteria:
  • Age enough 18 years old or older.
  • Diagnosed with stroke (based on hospital discharge papers or brain CT-scan or brain MRI results, if available).
  • During the recovery period (24 hours - 6 months) according to the classification of KNGF
  • Has subluxated shoulder joint (assessed on X-ray of straight shoulder joint according to Van Langenberghe and Hogan criteria)
  • Volunteer to sign the consent form to participate in the study.

排除标准

  • Patients not be selected for the study if they have any one of the following conditions:
  • Have previous shoulder pathology not related to stroke such as tumor, infection, scapular instability, winged scapula, brachial plexus injury, periarthritis humeroscapularis (recorded through asking about the patient's history)
  • Have skin infections and ulcers in the paralyzed shoulder area.
  • Have a blood clotting disorder or lack of clotting factors (recorded through asking the patient's history).
  • Pregnant women.

结局指标

主要结局

The grade of shoulder subluxation was measured according to Hall J's quantitative method

时间窗: After 4 weeks of intervention

The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan

时间窗: After 4 weeks of intervention

Classification of treatment response according to shoulder subluxation grade (the qualitative method of Van Langenberghe and Hogan)

时间窗: After 4 weeks of intervention

次要结局

未报告次要终点

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bui Pham Minh Man

medicine doctor

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

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