Shoulder PainNCT04683705
Ultrasound Measurement of the Suprascapular Nerve
An observational study of Shoulder Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Ultrasound
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to Jul 2023
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients (≥ 20 year old). All the participants were those visiting the department of physical medicine and rehabilitation for musculoskeletal complaints.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Bei-Hu Branch
Taipei
Ke-Vin Chang, +886-23717101 ext. 5309, kvchang011@gmail.com
About this study
Official title: Ultrasound Measurement of the Suprascapular Nerve in Asymptomatic and Painful Shoulders
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.
Read the detailed description
Introduction:
Shoulder pain arises to be one of the most common musculoskeletal complaints. 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 suprascapular 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 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.
Material and methods:
Study design:
This was a cross-sectional study investigating suprascapular nerves in the asymptomatic and painful shoulders of participants. All the participants were required to ambulate independently, have normal cognitive function and complete the given questionnaires. Both groups included at least 60 participants.
Detail of the investigation
- High-resolution ultrasound evaluation of the shoulder region to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon.
- 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.
- 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).
- 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 identification for the images of the rotator cuff lesions or biceps tendon lesions were conducted by another specialist.
- Comparison of age, body height, body weight, and CSA across various age and sex groups were conducted.
Statistical analysis:
- Continuous variables: Mann Whitney u test
- Categorical variables: Chi-square test
- Conditions
- Shoulder Pain
- Being tested
- Ultrasound
- Keywords
- Ultrasonography, Rotator cuff, Suprascapular Nerve, Pain
- Medical subject headings
- Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
- High-resolution ultrasound evaluation of the shoulder region to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon.
- 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.
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: During/at recruitment.
Visual analogue scale
The pain scale to evaluate pain, from 0 to 10. The lower means less pain.
Measured: During/at recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jun 2018
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke-Vin Chang, MD,PhD, Study chair, National Taiwan University Hospital Beihu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683705
- Sponsor's protocol ID
- 20180405RIND
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurement of the Suprascapular Nerve in Asymptomatic and Painful Shoulders
- ClinicalTrials.gov ID
- NCT04683705
- Acronym / sponsor ID
- 20180405RIND
- Conditions
- Shoulder Pain
- Keywords
- Ultrasonography, Rotator cuff, Suprascapular Nerve, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 24 Dec 2020 (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.
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.
Detailed description
Introduction:
Shoulder pain arises to be one of the most common musculoskeletal complaints. 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 suprascapular 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 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.
Material and methods:
Study design:
This was a cross-sectional study investigating suprascapular nerves in the asymptomatic and painful shoulders of participants. All the participants were required to ambulate independently, have normal cognitive function and complete the given questionnaires. Both groups included at least 60 participants.
Detail of the investigation
- High-resolution ultrasound evaluation of the shoulder region to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon.
- 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.
- 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).
- 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 identification for the images of the rotator cuff lesions or biceps tendon lesions were conducted by another specialist.
- Comparison of age, body height, body weight, and CSA across various age and sex groups were conducted.
Statistical analysis:
- Continuous variables: Mann Whitney u test
- Categorical variables: Chi-square test
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients without shoulder pain | – | Diagnostic Test: UltrasoundThis 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. |
| patients with shoulder pain | – | Diagnostic Test: UltrasoundThis 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients (≥ 20 year old). All the participants were those visiting the department of physical medicine and rehabilitation for musculoskeletal complaints.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Ultrasound1. 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). | Diagnostic test | patients with shoulder pain, patients without shoulder pain |
Primary outcome
Nerve cross-sectional area
Time frame: During/at recruitment.
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 Chinese version of the Shoulder Pain and Disability Index (SPADI) tool
Time frame: During/at recruitment.
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.
Visual analogue scale
Time frame: During/at recruitment.
The pain scale to evaluate pain, from 0 to 10. The lower means less pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Ke-Vin Chang, MD,PhD study chair
National Taiwan University Hospital Beihu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Dec 2020. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-Vin Chang, MD,PhD (+886-23717101 ext. 5309, kvchang011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve cross-sectional area (time frame: During/at recruitment.). 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?
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 24 Dec 2020.