Ultrasound Measurement of the Suprascapular Nerve

NCT04683705 | Unknown

• 1 other identifier: 20180405RIND
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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 divided from the upper trunk, the suprascapular nerve goes laterally and posteriorly. First, it passes underneath omohyoid muscle, and then goes through the suprascapular notch and into the suprascapular fossa. At suprascapular fossa, the suprascapular nerve is just below supraspinatus muscle. If there are some problems inside the supraspinatus muscle, the suprascapular nerve below it could be compromised. After suprascapular nerve passes suprascapular fossa, it will cross spinoglenoid notch, then go into infraspinatus fossa and innervates infraspinatus muscle. Based on the important distribution of suprascapular nerve to the sensory and motor function of shoulder joint, it has great benefits to understand its normal and abnormal sonographic images in order to diagnose refractory shoulder pain cases. Although there are some studies trying to measure the size of suprascapular nerve, most of them are limited in its location at the supraspinatus fossa. Also, they do not take factors into consideration, such as the subject's sex, body index, orientation and if shoulder pain or not at that point. In conclusion, our study is aimed to explore the difference of the suprascapular nerves between the participants with and without shoulder pain and to investigate potential factors that may influence the nerve's size using high-resolution ultrasound.

Conditions

Shoulder Pain

Keywords

Ultrasonography; Rotator cuff; Suprascapular Nerve; Pain

Outcome Measures

Primary Outcomes (3)

• Nerve cross-sectional area

  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.

  During/at recruitment.

• The Chinese version of the Shoulder Pain and Disability Index (SPADI) tool

  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.

  During/at recruitment.

• Visual analogue scale

  The pain scale to evaluate pain, from 0 to 10. The lower means less pain.

  During/at recruitment.

Study Arms (2)

patients without shoulder pain

This was a cross-sectional study investigating suprascapular nerves in the asymptomatic shoulders of participants. All the participants were required to ambulate independently, have normal cognitive function and complete the given questionnaires. The group included at least 60 participants.

Diagnostic Test: Ultrasound

patients with shoulder pain

This was a cross-sectional study investigating suprascapular nerves in the painful shoulders of participants. All the participants were required to ambulate independently, have normal cognitive function and complete the given questionnaires. The group included at least 60 participants.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

1. High-resolution ultrasound evaluation of the shoulder region to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon. 2. High-resolution ultrasound evaluation 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. Collecting 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).

patients with shoulder pain; patients without shoulder pain

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

Participants: Adult patients (≥ 20 year old). All the participants were those visiting the department of physical medicine and rehabilitation for musculoskeletal complaints. Control : Healthy asymptomatic volunteers, 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, and suprascapular nerve block on either side of the shoulders within the three months.

You may qualify if:

• Adult 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ke-Vin Chang, MD,PhD

  National Taiwan University Hospital Bei-Hu Branch

  STUDY CHAIR

Central Study Contacts

Ke-Vin Chang, MD,PhD

CONTACT

+886-23717101; kvchang011@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)