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

NCT ID: NCT06545357

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-06-18

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.

Conditions

Shoulder Subluxation After Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

My-Suong Thi Phan

UNKNOWN

Sponsor Role: collaborator

Dieu-Thuong Thi Trinh

UNKNOWN

Sponsor Role: collaborator

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Bui Pham Minh Man

medicine doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Ho Chi Minh City, , Vietnam

Countries

Vietnam

References

Wang RY, Chan RC, Tsai MW. Functional electrical stimulation on chronic and acute hemiplegic shoulder subluxation. Am J Phys Med Rehabil. 2000 Jul-Aug;79(4):385-90; quiz 391-4. doi: 10.1097/00002060-200007000-00011.

Reference Type: RESULT

PMID: 10892625 (View on PubMed)

Koyuncu E, Nakipoglu-Yuzer GF, Dogan A, Ozgirgin N. The effectiveness of functional electrical stimulation for the treatment of shoulder subluxation and shoulder pain in hemiplegic patients: A randomized controlled trial. Disabil Rehabil. 2010;32(7):560-6. doi: 10.3109/09638280903183811.

Reference Type: RESULT

PMID: 20136474 (View on PubMed)

Manigandan JB, Ganesh GS, Pattnaik M, Mohanty P. Effect of electrical stimulation to long head of biceps in reducing gleno humeral subluxation after stroke. NeuroRehabilitation. 2014;34(2):245-52. doi: 10.3233/NRE-131041.

Reference Type: RESULT

PMID: 24419017 (View on PubMed)

Van Langenberghe HV, Hogan BM. Degree of pain and grade of subluxation in the painful hemiplegic shoulder. Scand J Rehabil Med. 1988;20(4):161-6.

Reference Type: RESULT

PMID: 3232046 (View on PubMed)

Hall J, Dudgeon B, Guthrie M. Validity of clinical measures of shoulder subluxation in adults with poststroke hemiplegia. Am J Occup Ther. 1995 Jun;49(6):526-33. doi: 10.5014/ajot.49.6.526.

Reference Type: RESULT

PMID: 7645665 (View on PubMed)

Pyace Phyo Nyein, Myat Bhone Aung, Thein Than Win, Khin Win Sein. Effects of electrical stimulation to long head of biceps in glenohumeral subluxation after stroke.ResearchGate. 2020;doi:10.13140/RG.2.2.28053.06886

Reference Type: RESULT

Other Identifiers

702/HDDD-DHYD

Identifier Type: -

Identifier Source: org_study_id