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

NCT05064891 | Enrolling By Invitation

• 1 other identifier: 202104006RIND
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Ultrasonography; Stroke; Suprascapular Nerve; Pain

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• Dynamic shoulder motion under ultrasound imaging

  Subacromial motion metrics, based on the reciprocol movement of the greater tubercle of the humerus in relation to the acromion

  Baseline and after intervention (if available)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Stroke patients

Procedure: Ultrasound guided injection

Participants without stroke

Interventions

Ultrasound guided injection PROCEDURE

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

Stroke patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 26135374 RESULT

• 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.

  PMID: 26453125 RESULT

• 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.

  PMID: 26701762 RESULT

• 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.

  PMID: 27676661 RESULT

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-Vin Chang, MD,PhD

  National Taiwan University Hospital Bei-Hu Branch

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 1, 2021
• Study Start: December 13, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)