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Clinical Trials/NCT06545357
NCT06545357
Completed
N/A

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 City1 site in 1 country72 target enrollmentJuly 28, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Shoulder Subluxation After Stroke
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Enrollment
72
Locations
1
Primary Endpoint
The grade of shoulder subluxation was measured according to Hall J's quantitative method
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 28, 2023
End Date
June 18, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible Party
Principal Investigator
Principal Investigator

Bui Pham Minh Man

medicine doctor

University of Medicine and Pharmacy at Ho Chi Minh City

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: After 4 weeks of intervention

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

Time Frame: After 4 weeks of intervention

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

Time Frame: After 4 weeks of intervention

Study Sites (1)

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