Clinical trial NCT06545357: Effective Treatment of Shoulder Subluxation After Stroke With Modified Acupuncture of Biceps Brachii Muscle, Supraspinatus Muscle and Deltoid Muscle
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Subluxation After Stroke
Keywords: Shoulder subluxation after stroke
Modified acupuncture
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: My-Suong Thi Phan
name: Dieu-Thuong Thi Trinh
First posted: 2024-08-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan
timeFrame: After 4 weeks of intervention
measure: The grade of shoulder subluxation was measured according to Hall J's quantitative method
timeFrame: After 4 weeks of intervention
measure: Classification of treatment response according to shoulder subluxation grade (the qualitative method of Van Langenberghe and Hogan)
timeFrame: After 4 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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