Ultrasound Application on the Suprascapular Nerve for Stroke Patients

Stroke Clinical Trial

Official title:

Application of Ultrasound Imaging of Suprascapular Nerves and Dynamic Shoulder Movement for Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064891
• Other study ID #: 202104006RIND
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2021
• Source: National Taiwan University Hospital
• Contact: Ke-Vin Chang, MD,PhD
• Phone: +886-23717101 Ext. 5309
• Email: kvchang011[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Bei-Hu Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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 — View Citation

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 — View Citation

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. Revi — View Citation

Wu CH, Chang KV, Özçakar 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve cross-sectional area at the recruited time	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.	at the recruited time
Primary	Change from the baseline of nerve cross-sectional area after the injection	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.	at one month later after the injection
Primary	The Chinese version of the Shoulder Pain and Disability Index at the recruited time	The Chinese version of the Shoulder Pain and Disability Index (SPADI) tool. The SPADI tool consisted of 13 questions categorized in two domains: pain and disability. They were instructed to indicate the level of influence on a 10 cm visual analogue scale for each question with a rating from 0 (no pain or no difficulty) to 10 (worst pain or extreme difficulty). The scores from the pain and functional domains were averaged to generate the total score of SPADI, with a highest value of 100 points.	at the recruited time
Primary	Change from the baseline of The Chinese version of the Shoulder Pain and Disability Index at recruited time after the injection	The Chinese version of the Shoulder Pain and Disability Index (SPADI) tool. The SPADI tool consisted of 13 questions categorized in two domains: pain and disability. They were instructed to indicate the level of influence on a 10 cm visual analogue scale for each question with a rating from 0 (no pain or no difficulty) to 10 (worst pain or extreme difficulty). The scores from the pain and functional domains were averaged to generate the total score of SPADI, with a highest value of 100 points.	at one month later after the injection
Primary	Visual analogue scale at the recruited time	The pain scale to evaluate pain, from 0 to 10. The lower means less pain.	at the recruited time
Primary	Change from the baseline of Visual analogue scale after the injection	The pain scale to evaluate pain, from 0 to 10. The lower means less pain.	at one month later after the injection
Primary	Range of the motion and impingement at the recruited time	Range of the motion of the shoulder, from 0 degree to 180 degree. The lower means more limitation. The impingement of supraspinatus tendon, subdeltoid bursa and acromion are evaluated under ultrasonography. The transducer is positioned along the scapular plane lateral to the acromion. The participant gradually raises the arm, and the examiner simultaneously observes whether there is bulging of the subacromial bursa and abnormal elevation/movement of the humeral head.	at the recruited time
Primary	Change from the baseline of range of the motion and impingement after the injection	Range of the motion of the shoulder, from 0 degree to 180 degree. The lower means more limitation. The impingement of supraspinatus tendon, subdeltoid bursa and acromion are evaluated under ultrasonography. The transducer is positioned along the scapular plane lateral to the acromion. The participant gradually raises the arm, and the examiner simultaneously observes whether there is bulging of the subacromial bursa and abnormal elevation/movement of the humeral head.	at one month later after the injection