Ultrasound Application on the Suprascapular Nerve and Dynamic Shoulder Movement for Stroke Patients

NCT ID: NCT05064891

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2026-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The suprascapular nerve is the first nerve that branches from the upper trunk of brachial plexus. It receives signals transmitted from the fifth and sixth cervical root. The clinical importance of suprascapular nerve is mainly based on its distribution of 70% sensory innervation to the glenohumeral joint. After being divided from the upper trunk, the suprascapular nerve goes laterally and posteriorly. First, it passes underneath the omohyoid muscle, and then goes through the suprascapular notch into the suprascapular fossa. If there are some problems inside the supraspinatus muscle at the suprascapular fossa, the suprascapular nerve below it may be compromised. After the suprascapular nerve passes the suprascapular fossa, it courses through the spinoglenoid notch, and then goes into the infraspinatus fossa to innervate the infraspinatus muscle. Based on the sensory and motor innervation of the suprascapular nerve to the shoulder joint, the sonographic images of the suprascapular nerves would add tremendous values in assessing patients with refractory shoulder pain. Although there are some studies trying to measure the size of the suprascapular nerve, no available research can be found in stroke patients. Our study aims to explore the ultrasound morphology of the suprascapular nerves as well as subacromial dynamic imaging in patients with stroke. A control group without stroke will be recruited for comparison.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction:

Shoulder pain arises to be one of the most common musculoskeletal complaints, and with the high prevalence in stroke patients. The mechanism of an increased risk of painful shoulders is multifactorial and the role of the suprascapular nerve in development and management of shoulder pain has been highlighted recently. In recent years, high resolution ultrasound has been widely applied on evaluation of entrapment neuropathy, and its reliability on assessing the cross-sectional area of supraspcapular nerves has been validated. As the suprascapular nerve is crucial for conducting shoulder motion and sensation, it is of clinical importance to measure the size of suprascapular nerve. Our study aims to explore the ultrasound morphology of the suprascapular nerves as well as subacromial dynamic imaging in patients with stroke and to investigate the nerve's size after ultrasound-guided injection.

Material and methods:

Participants: Adult stroke patients (≥ 20 year old).

Control: Asymptomatic adult subjects (≥20 year old)

Exclusion criteria:

The exclusion criteria included history of malignancy, uncontrolled medical conditions (like systemic rheumatic disease, including rheumatic arthritis and ankylosing spondylitis), previous major trauma or surgeries, suprascapular nerve block on either side of the shoulders within the three months, and the patients with specific aphasia and poor cognition.

Study design:

This was a longitudinal follow-up study investigating the suprascapular nerves, the dynamic subacromial examination of shoulder, and the nerve's size after ultrasound-guided injection in patients with stroke. All the participants were required to ambulate independently, have normal cognitive function and complete the given questionnaires. The study included at least 60 participants.

Detail of the investigation

1. High-resolution ultrasound evaluation of the shoulder region was applied to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon.
2. High-resolution ultrasound evaluation was applied for the C5, C6 and C7 nerve roots and the suprascapular nerve over the supraclavicular fossa, in the supraspinatus fossa and in the infraspinatus fossa to obtain the nerve cross-sectional image.
3. High-resolution ultrasound evaluation was applied for the dynamic examination of the shoulder to recognize the impingement of the shoulder.
4. The investigators collected the shoulder pain-related information, including physical examination results (bicipital groove tenderness, Speed test, Yergason's test, Empty can test, Neer test, Hawkins-Kennedy test and painful arc test) and status of disability using Shoulder Pain and Disability Index (SPADI).
5. The investigators collected the information of the types of the stroke, onset times, and functional status, including Bathel index and Fugl-Meyer Upper Extremity Assessment.

Outcome measurement:

Primary outcome:

1. The measurements of the nerve cross-sectional area were conducted by another specialist with the image processing software (Image J). For the most proximal section of the suprascapular nerve, the cross-section of the nerve fascicles inside the hyperechoic epineurium were measured. In the segment over the supraspinatus and infraspinatus fossae, the whole nerve's cross-section including its epineurium were measured. The data collection was performed at the initial recruitment and one month later after the injection.
2. The Chinese version of the Shoulder Pain and Disability Index (SPADI) tool. The data collection was performed at the initial recruitment and one month later after the injection.
3. Visual analogue scale. The data collection was performed at the initial recruitment and one month later after the injection.
4. The range of the motion and impingement of the shoulder under dynamic subacromial examination. The data collection was performed at the initial recruitment and one month later after the injection.

Statistical analysis:

1. Continuous variables: Mann Whitney u test
2. Categorical variables: Chi-square test

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stroke patients

Ultrasound guided injection

Intervention Type PROCEDURE

Subdeltoid bursa injection, suprascapular nerve block, or posterior glenohumeral joint injection. The participants should only receive one type of the injection mentioned above.

Participants without stroke

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound guided injection

Subdeltoid bursa injection, suprascapular nerve block, or posterior glenohumeral joint injection. The participants should only receive one type of the injection mentioned above.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult and stroke patients (≥ 20 year old). All the participants were those visiting the department of physical medicine and rehabilitation for musculoskeletal complaints.

Exclusion Criteria

* History of malignancy
* Uncontrolled medical conditions (like systemic rheumatic disease, including rheumatic arthritis and ankylosing spondylitis).
* Previous major trauma or surgeries, and suprascapular nerve block on either side of the shoulders within the three months.
* The patients with specific aphasia and poor cognition.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ke-Vin Chang, MD,PhD

Role: STUDY_CHAIR

National Taiwan University Hospital Bei-Hu Branch

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital, Bei-Hu Branch

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Wu CH, Chang KV, Ozcakar L, Hsiao MY, Hung CY, Shyu SG, Wang TG, Chen WS. Sonographic tracking of the upper limb peripheral nerves: a pictorial essay and video demonstration. Am J Phys Med Rehabil. 2015 Sep;94(9):740-7. doi: 10.1097/PHM.0000000000000344.

Reference Type RESULT
PMID: 26135374 (View on PubMed)

Chang KV, Hung CY, Wang TG, Yang RS, Sun WZ, Lin CP. Ultrasound-Guided Proximal Suprascapular Nerve Block With Radiofrequency Lesioning for Patients With Malignancy-Associated Recalcitrant Shoulder Pain. J Ultrasound Med. 2015 Nov;34(11):2099-105. doi: 10.7863/ultra.14.12042. Epub 2015 Oct 9.

Reference Type RESULT
PMID: 26453125 (View on PubMed)

Chang KV, Hung CY, Wu WT, Han DS, Yang RS, Lin CP. Comparison of the Effectiveness of Suprascapular Nerve Block With Physical Therapy, Placebo, and Intra-Articular Injection in Management of Chronic Shoulder Pain: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2016 Aug;97(8):1366-80. doi: 10.1016/j.apmr.2015.11.009. Epub 2015 Dec 14.

Reference Type RESULT
PMID: 26701762 (View on PubMed)

Chang KV, Wu WT, Hung CY, Han DS, Yang RS, Chang CH, Lin CP. Comparative Effectiveness of Suprascapular Nerve Block in the Relief of Acute Post-Operative Shoulder Pain: A Systematic Review and Meta-analysis. Pain Physician. 2016 Sep-Oct;19(7):445-56.

Reference Type RESULT
PMID: 27676661 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202104006RIND

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parasagittal Vs Cornerpocket Approaches
NCT06352333 NOT_YET_RECRUITING NA