Rheumatoid ArthritisNCT01746966
Anterior Shoulder US - a New Access
An observational study of Rheumatoid Arthritis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
1. Investigate Gleno-Humeral Joint (GHJ) by anterior approach: A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees By longitudinal access with transducer position laterally to coracoids along… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Sep 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20 healthy controls from department of preventive medicine and 20 patients with Rheumatoid Arthritis age of 20-60
Who may be able to join
- Healthy controls age of 20-60 according to conclusion of preventive medicine department
- Patients with RA according to ARA 1987 revised criteria and disease activity DAS 3-5
Who cannot join
- Past shoulder trauma
- Shoulder osteoarthritis
- Rotator cuff disorders
- Shoulder injections
- Cervical spondylosis with nerve root compression, Cervical symptomatic disc syndromes
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rheumatology unit
Haifa, 31096
Alexander Rozin, MD, 972-48542268, a_rozin@rambam.health.gov.il
Amir Dagan, MD
About this study
Official title: US Investigation of Gleno-humeral Joint by Anterior Access With Measurement of Rotator Interval in Patients With Rheumatoid Arthritis and Healthy Controls
- Investigate Gleno-Humeral Joint (GHJ) by anterior approach: A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees
- By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4)
- By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7). B - Measurement of rotator interval with assessment of width and higher.
- Comparison of the data with results of classic values have been received by posterior and inferior (axillar) approach.
- Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy controls
Read the detailed description
US scan was shown to be effective and useful for investigation of shoulder diseases. It is easy to implement and return, not expensive and not invasive, and precise for assessment. Glenohumeral joint is most inspected in elderly population. Most of shoulder syndromes are not related to joint diseases, but to adjacent tissue problem. However, US is preferred method for assessment GHJ by rheumatologists. But inflammatory changes in GHJ found limited attention in medical imaging literature. So far there is assessment of GHJ synovitis with disclosure of synovial fluid and pannus in subdeltoid (subacromial) bursa and biceps tendon, connected to GHJ space, by axillar and posterior access. Subdeltoid bursitis and biceps tenosynovitis are common used for inflammatory assessment of the shoulder. Anterior approach for GHJ assessment has not been used before our last trial. A problem of patients with synovitis in GHJ is difficulties to pick up shoulder to lateral side (abduction) till 90 degrees for axillar approach. We proposed anterior access for GHJ synovitis assessment. Certain position of the shoulder and measured data of healthy controls enabled diagnostic of GHJ synovitis with minimal movement of ill shoulder. In other report we showed US differences between GHJ and subscapular tendon on the anterior approach. These two publications showed anterior shoulder US in sitting position with arm externally rotated and supinated. We should recognize problems of these trials related to wrong identification of GHJ space. As we realized later this incorrect detection was associated with missing two orienteer structures: GHJ cartilage located behind and subcscapular tendon situated forward to GHJ space. From our present view, these two criteria are corn stone for GHJ visualization. Because lack obvious picture of these 2 structures GHJ demonstration is unclear and exposed to confusion with subscapular tendon. Moreover, our further experience of multiple anterior US studies showed that presentation of GHJ in position for supination and external rotation in sitting position is associated with poor visualization of GHJ cavity. The reason is position of GHJ to be hidden behind humeral head due to differences between round humeral head and oval glenoid and twist GHJ structure forward-upper-laterally. Daily practice helped to resolve the problem. We found: a patient should be laid down supine, his elbow is bent to 90 degrees and the shoulder is rotated maximally externally. This condition is associated to fix shoulder girdle, glenoid move anteriorly, humeral head move posteriorly, and much more complete external shoulder rotation is achieved opening GHJ for investigation. Shoulder CT shows that glenoid surface is in plane open to upper, forward and lateral side. It obligates to turn of transducer according to direction of investigated joint placed along the glenoid surface. That means, longitudinal study of GHJ requests transducer position under certain angle along to joint line. Transversal study is implemented under angle 90 degree to the joint line. Other problem is that synovitis may developed at early stage only within limited region of the joint and in region much more susceptible to inflammation and dilatation, like that rotator interval: anterior upper region which is covered only by the joint capsule with lower resistance to distention. That region is referred as rotator interval, a distance between supraspinatus (laterally) and subcapularis (medially) tendons attachment, when shoulder supinated and externally rotated. This region has been recently used for synovial biopsy.
Materials and methods:
US will be performed for 20 healthy controls and 20 patients with RA. US scan will be fulfilled symmetric both sides. Diagnosis RA is relied on anamnesis data, physical examination, and laboratory findings. Synovial swelling, synovial tenderness, local fever of joint region, active and passive limitation, accelerated erythrocyte sedimentation rate(ESR) upper 40mm/hr (N<12), C reactive protein (CRP) upper 1.5mg/dl (N<0.5) were clinical signs of active inflammation. Twenty healthy controls did not complain of shoulder pain and limitation and their physical examination was unremarkable.
Study process:
US scan will be performed as prospective study for 20 healthy controls from department of preventive medicine and for 20 patients with RA age of 20-60 by to classic approaches: posterior and inferior and new anterior access. The last was accompanied by measurement of GHJ space and rotator interval in upper limb position of supination and external rotation. Comparison will be implemented between data of different positions and RA patients compared with controls.
- Conditions
- Rheumatoid Arthritis
- Keywords
- gleno-humeral joint synovitis, anterior shoulder US, rotator interval
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | 20 patients age of 20-60 with Rheumatoid Arthritis according to ARA 1987 revised criteria and disease activity Disease Activity Score (DAS) 3-5 | |
| Healthy controls participants | Healthy controls age of 20-60 according to conclusion of preventive medicine department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of GHJ thickness and of rotator interval
A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees
- By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4)
- By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7).
B - Measurement of rotator interval with with assessment of width and higher.
Measured: Six months
Secondary outcomes (2)
Data of comparison between measurement of GHJ in anterior and axillar access and anterior and posterior access in patients with Rheumatoid Arthritis and Controls.
Measured: Eight months
Data of comparison in measurement of rotator interval in patients with Rheumatoid Arthritis and controls.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Rozin, MD, Principal investigator, Rambam Health Care Campus and Technion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746966
- Sponsor's protocol ID
- 0260-10CTIL
- Status last verified
- May 2014
- First submitted
- 22 Nov 2012
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Investigation of Gleno-humeral Joint by Anterior Access With Measurement of Rotator Interval in Patients With Rheumatoid Arthritis and Healthy Controls
- ClinicalTrials.gov ID
- NCT01746966
- Acronym / sponsor ID
- 0260-10CTIL
- Conditions
- Rheumatoid Arthritis
- Keywords
- gleno-humeral joint synovitis, anterior shoulder US, rotator interval
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- 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.
- Investigate Gleno-Humeral Joint (GHJ) by anterior approach: A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees
- By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4)
- By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7). B - Measurement of rotator interval with assessment of width and higher.
- Comparison of the data with results of classic values have been received by posterior and inferior (axillar) approach.
- Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy controls
Detailed description
US scan was shown to be effective and useful for investigation of shoulder diseases. It is easy to implement and return, not expensive and not invasive, and precise for assessment. Glenohumeral joint is most inspected in elderly population. Most of shoulder syndromes are not related to joint diseases, but to adjacent tissue problem. However, US is preferred method for assessment GHJ by rheumatologists. But inflammatory changes in GHJ found limited attention in medical imaging literature. So far there is assessment of GHJ synovitis with disclosure of synovial fluid and pannus in subdeltoid (subacromial) bursa and biceps tendon, connected to GHJ space, by axillar and posterior access. Subdeltoid bursitis and biceps tenosynovitis are common used for inflammatory assessment of the shoulder. Anterior approach for GHJ assessment has not been used before our last trial. A problem of patients with synovitis in GHJ is difficulties to pick up shoulder to lateral side (abduction) till 90 degrees for axillar approach. We proposed anterior access for GHJ synovitis assessment. Certain position of the shoulder and measured data of healthy controls enabled diagnostic of GHJ synovitis with minimal movement of ill shoulder. In other report we showed US differences between GHJ and subscapular tendon on the anterior approach. These two publications showed anterior shoulder US in sitting position with arm externally rotated and supinated. We should recognize problems of these trials related to wrong identification of GHJ space. As we realized later this incorrect detection was associated with missing two orienteer structures: GHJ cartilage located behind and subcscapular tendon situated forward to GHJ space. From our present view, these two criteria are corn stone for GHJ visualization. Because lack obvious picture of these 2 structures GHJ demonstration is unclear and exposed to confusion with subscapular tendon. Moreover, our further experience of multiple anterior US studies showed that presentation of GHJ in position for supination and external rotation in sitting position is associated with poor visualization of GHJ cavity. The reason is position of GHJ to be hidden behind humeral head due to differences between round humeral head and oval glenoid and twist GHJ structure forward-upper-laterally. Daily practice helped to resolve the problem. We found: a patient should be laid down supine, his elbow is bent to 90 degrees and the shoulder is rotated maximally externally. This condition is associated to fix shoulder girdle, glenoid move anteriorly, humeral head move posteriorly, and much more complete external shoulder rotation is achieved opening GHJ for investigation. Shoulder CT shows that glenoid surface is in plane open to upper, forward and lateral side. It obligates to turn of transducer according to direction of investigated joint placed along the glenoid surface. That means, longitudinal study of GHJ requests transducer position under certain angle along to joint line. Transversal study is implemented under angle 90 degree to the joint line. Other problem is that synovitis may developed at early stage only within limited region of the joint and in region much more susceptible to inflammation and dilatation, like that rotator interval: anterior upper region which is covered only by the joint capsule with lower resistance to distention. That region is referred as rotator interval, a distance between supraspinatus (laterally) and subcapularis (medially) tendons attachment, when shoulder supinated and externally rotated. This region has been recently used for synovial biopsy.
Materials and methods:
US will be performed for 20 healthy controls and 20 patients with RA. US scan will be fulfilled symmetric both sides. Diagnosis RA is relied on anamnesis data, physical examination, and laboratory findings. Synovial swelling, synovial tenderness, local fever of joint region, active and passive limitation, accelerated erythrocyte sedimentation rate(ESR) upper 40mm/hr (N<12), C reactive protein (CRP) upper 1.5mg/dl (N<0.5) were clinical signs of active inflammation. Twenty healthy controls did not complain of shoulder pain and limitation and their physical examination was unremarkable.
Study process:
US scan will be performed as prospective study for 20 healthy controls from department of preventive medicine and for 20 patients with RA age of 20-60 by to classic approaches: posterior and inferior and new anterior access. The last was accompanied by measurement of GHJ space and rotator interval in upper limb position of supination and external rotation. Comparison will be implemented between data of different positions and RA patients compared with controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | –20 patients age of 20-60 with Rheumatoid Arthritis according to ARA 1987 revised criteria and disease activity Disease Activity Score (DAS) 3-5 |
| Healthy controls participants | – | –Healthy controls age of 20-60 according to conclusion of preventive medicine department |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 healthy controls from department of preventive medicine and 20 patients with Rheumatoid Arthritis age of 20-60
Key inclusion criteria (2 listed)
- Healthy controls age of 20-60 according to conclusion of preventive medicine department
- Patients with RA according to ARA 1987 revised criteria and disease activity DAS 3-5
Key exclusion criteria (5 listed)
- Past shoulder trauma
- Shoulder osteoarthritis
- Rotator cuff disorders
- Shoulder injections
- Cervical spondylosis with nerve root compression, Cervical symptomatic disc syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of GHJ thickness and of rotator interval
Time frame: Six months
A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees * By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4) * By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7). B - Measurement of rotator interval with with assessment of width and higher.
2 secondary outcomes
Data of comparison between measurement of GHJ in anterior and axillar access and anterior and posterior access in patients with Rheumatoid Arthritis and Controls.
Time frame: Eight months
Data of comparison in measurement of rotator interval in patients with Rheumatoid Arthritis and controls.
Time frame: Eight months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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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.
Alexander Rozin, MD principal investigator
Rambam Health Care Campus and Technion
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 Rheumatoid Arthritis, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 5 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 6 May 2014. 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 Israel. 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 Alexander Rozin, MD (972-48542268, a_rozin@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of GHJ thickness and of rotator interval (time frame: Six months). 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 6 May 2014.