Effective Treatment of Shoulder Subluxation After Stroke With Modified Acupuncture of Biceps Brachii Muscle, Supraspinatus Muscle and Deltoid Muscle

August 7, 2024 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam
        • Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 2014.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The intervention group
36 participants received upright shoulder X-rays before intervention to evaluate shoulder subluxation. Participants of the intervention group were received modified acupuncture to improve the biceps brachii muscle, supraspinatus muscle and deltoid muscle; The degree of shoulder subluxation will be evaluated by X-ray of the shoulder joint after 4 weeks of intervention.
Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture at biceps brachii muscle, supraspinatus muscle and deltoid muscles or acupoints on The Yang Ming Channel for 20 minutes, frequency ≤ 20 Hz, intensity from 2- 10mA
Sham Comparator: The control group
36 participants received upright shoulder X-rays before intervention to evaluate shoulder subluxation. Participants of the control group were received conventional electroacupuncture according to The Stomach Channel -Yangming; The degree of shoulder subluxation will be evaluated by X-ray of the shoulder joint after 4 weeks of intervention.
Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture at biceps brachii muscle, supraspinatus muscle and deltoid muscles or acupoints on The Yang Ming Channel for 20 minutes, frequency ≤ 20 Hz, intensity from 2- 10mA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan
Time Frame: After 4 weeks of intervention
After 4 weeks of intervention
The grade of shoulder subluxation was measured according to Hall J's quantitative method
Time Frame: After 4 weeks of intervention
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
After 4 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Collaborators

My-Suong Thi Phan
Dieu-Thuong Thi Trinh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

June 18, 2024

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 702/HDDD-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographic characteristic and outcome data will be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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