Organization of distinct etiological mechanisms for symptoms clinically diagnosed as SIS, into several identifiable subgroups of patients (relative cranialisation of the humerus, structural narrowing of the subacromial space, subacromial…
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Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
- Cranial translation of the humerus as measured on AP-radiographs in rest, and
with a constant abduction and adduction force exertion against an force
transducer
- Scapulohumeral rhythm and shoulder-arm Range of Motion as measured with an
electromagnetic motion tracking device.
Secondary outcome
All study parameters categorized for etiological subgroups:
1) Relative cranial translation of the humerus: 3D arm-scapula motion
registration (3D RoM), muscle activation parameters of shoulder and rotator
cuff muscles (EMG), static acromiohumeral distance (sAH) on AP-radiographs *at
rest* and with exerted ab- and adduction moments (dAH), integrate bony 3D-shape
with 3D RoM to describe dynamic AH (3DdAH).
2) Structural (bony) narrowing of the subacromial space: shape parameters of
scapula (i.e. Bigliani acromion classification) and humerus, 3D kinematic
analysis of scapulo-humeral motion by integration of bony 3D-shapes with 3D
RoM.
3) Subacromial inflammatory processes and damaged tissues: MRI for rotator cuff
and muscle quality (Goutallier score) and signs of bursitis, tendinitis and
rotator cuff ruptures.
4) Other primary pathologies leading to SIS complaints: evaluation of MRI and
radiographs for acromioclavicular-osteoarthritis, full thickness rotator
cuff-ruptures, coracoid impingement and other subacromial pathologies.
Background summary
The subacromial impingement syndrome (SIS) is the most prevalent disorder of
the shoulder in primary health care. Acromionplasty, as the main surgical
treatment of SIS, is one of the most performed orthopedic surgeries.
The etiology of the primary SIS is not clearly understood, but surgical
treatment is primarily focused at the extrinsic mechanism as described by Neer:
the anterior part of the acromion painfully impinges on the subacromial tissues
and therefore must be resected. Nevertheless, variable results of this
frequently performed procedure have been reported (successful in 48- 90%), and
there are numerous publications of successful (conservative) treatments without
changing the coracoacromial shape.
There is a lot of debate on the etiology of SIS. Several mechanisms have been
described: i.e. narrowing of the subacromial space caused by cranial
translation of the humerus in multidirectional instability, scapular
dyskinesia, or intrinsic mechanisms such as primary degenerative tendinopathy
of the rotator cuff.
In theory, impingement (*narrowing of the subacromial space*) can be caused by
several mechanisms. Our hypothesis is, that the extrinsic mechanism is only
valid for a subgroup of patients; complaints of SIS can be caused by
1) a pathologic pattern of arm-scapula movements caused by a disrupted balance
in muscle forces, leading to cranial translation of the humerus with respect to
the scapula, or
2) narrowing of the subacromial space because of anatomic variations (i.e. a
hooked acromion or humeral shape), or
3) a subacromial inflammatory reaction (i.e. caused by micro-trauma), or
4) secondary to an adjoining pathology (i.e. osteoarthritis in the
acromioclavicular(AC)-joint).
Study objective
Organization of distinct etiological mechanisms for symptoms clinically
diagnosed as SIS, into several identifiable subgroups of patients (relative
cranialisation of the humerus, structural narrowing of the subacromial space,
subacromial inflammatory processes, other primary pathologies), in order to
improve diagnostic and therapeutic strategies of SIS by designing concept
diagnostics and treatment flow charts for each subgroup.
Study design
Observational cohort study
Study burden and risks
Patients will be subjected to usual care treatment and diagnostics for shoulder
complaints, including a standard MRI-arthrogram and radiographs.
Patients will receive a subacromial injection with lidocaine for one of the
biomechanical test at the LUMC laboratory.
5 Additional radiographs will be performed: anterior-posterior (AP) radiographs
with isometric active adduction and active abduction against a force
transducer, and in rest on the affected arm and the sound arm.
At intake, investigations in the laboratory will take about 2 hours. Filling
out questionnaires (at home or at the hospital) will take 30 minutes.
In the 3 study related follow-up moments, patients will only be subjected to
questionnaires (30 minutes in total).
A potential benefit is the availability of thorough investigations for each
patient on short notice and long term follow-up. Additionally, the goal of this
study is to lead to more effective diagnostic and treatment strategies,
possibly preventing unnecessary surgery in the future.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
The clinical diagnosis of stage I or II SIS is made when one or more of the following mentioned factors exist, next to a positive Neer impingement test and a positive Hawkins test.;Patients* history:
- Diffuse unilateral shoulder pain for > 3 months;
- Pain during activities with abduction, retroflexion and/or internal rotation (i.e. closing the door, putting on jacket, overhead activities);
- Pain at night or incapable of lying on the shoulder.;Physical examination:
- Diffuse pain at palpation of the greater tuberosity;
- Disturbed scapulohumeral rhythm;
- Painful arc;
- No complaints or sings of pathologies on the contralateral shoulder;
- > 90 Degrees external rotation in 90 degrees of passive abduction (frozen shoulder);
- Positive Yocum test.
Exclusion criteria
Patients are excluded if one of the following characteristics is found:
- <35 Or > 60 years old
- Restrictions in passive movements of glenohumeral joint/frozen shoulder;
- History of fracture or dislocation of the shoulder;
- History of surgery around the shoulder (in anamnesis);
- Tumors;
- No informed consent;
- Clinical and radiographic signs of comorbidities or alternative diagnoses on the affected shoulder (glenohumeral instability, glenohumeral movement restriction, glenohumeral osteoarthritis or arthritis, rheumatic disorder, labrum lesions, a history of trauma on the affected shoulder, biceps muscle tendinitis, complete (full thickness) rotator cuff rupture, cervical radiculopathy, PASTA lesion, or calcifying tendinitis);
- Contralateral shoulder with clinical signs of shoulder complaints.
- Pacemaker or other electronic implants
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28090.058.09 |