Shoulder Subluxation After StrokeNCT06545357
Effective Treatment of Shoulder Subluxation After Stroke With Modified Acupuncture of Biceps Brachii Muscle, Supraspinatus Muscle and Deltoid Muscle
A study testing Acupuncture in people with Shoulder Subluxation After Stroke, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Subluxation After Stroke
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Jul 2023to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City
About this study
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
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
Read the 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
- Being tested
- Acupuncture
- Keywords
- Shoulder subluxation after stroke, Modified acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Active comparator | 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. Receives: Procedure: Acupuncture |
| The control group | Sham comparator | 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. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan
Measured: After 4 weeks of intervention
The grade of shoulder subluxation was measured according to Hall J's quantitative method
Measured: After 4 weeks of intervention
Classification of treatment response according to shoulder subluxation grade (the qualitative method of Van Langenberghe and Hogan)
Measured: After 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start28 Jul 2023
- Primary completion31 May 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shoulder Subluxation After StrokeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- My-Suong Thi Phan, Dieu-Thuong Thi Trinh
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545357
- Sponsor's protocol ID
- 702/HDDD-DHYD
- Status last verified
- Aug 2024
- First submitted
- 21 Jun 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Publications
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.
PubMed 10892625Koyuncu 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.
PubMed 20136474Manigandan 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.
PubMed 24419017Van 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.
PubMed 3232046Hall 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.
PubMed 7645665Pyace 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06545357
- Acronym / sponsor ID
- 702/HDDD-DHYD
- Conditions
- Shoulder Subluxation After Stroke
- Keywords
- Shoulder subluxation after stroke, Modified acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- My-Suong Thi Phan, Dieu-Thuong Thi Trinh
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Active comparator | Procedure: Acupuncture36 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. |
| The control group | Sham comparator | Procedure: Acupuncture36 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureTo 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 | Procedure or surgery | The control group, The intervention group |
Primary outcome
The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan
Time frame: 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
Classification of treatment response according to shoulder subluxation grade (the qualitative method of Van Langenberghe and Hogan)
Time frame: After 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 10892625Wang 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.
- Results publication: PubMed 20136474Koyuncu 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.
- Results publication: PubMed 24419017Manigandan 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.
- Results publication: PubMed 3232046Van 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.
- Results publication: PubMed 7645665Hall 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.
- Results publicationPyace 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
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
Related trials for Shoulder Subluxation After Stroke
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
Not yet recruiting
Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke
Glenohumeral Subluxation, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Shoulder Subluxation After Stroke, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan (time frame: After 4 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545357, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.