The primary purpose of this study is to prospectively evaluate the accuracy of intra-articular glenohumeral injections via the posterior approach with (incipient) adhesiva capsulitis (frozen shoulder). Furthermore the confidence of the giver in a…
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Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Questionaires:
- VAS (Visual Analoge Scale) Pain
- DASH (Disabilities of the Arm, Schoulder and Hand)
- SST (Simple Shoulder Test)
- Constant Murley Score
Injection corticosteroids/lidocaine/contrast:
An X-ray is made to see if the injection was placed intraarticular.
Secondary outcome
nvt
Background summary
Shoulder pain is a common complaint within the orthopedic practice.
Intra-articular glenohumeral injections take an important place in the
treatment and diagnosis of shoulder complaints. For diagnostic purposes, for
example a MRI arthrogram, a contrast agent is used. As treatment the injection
contains usually corticosteroids (Depomedrol) and an analgesic (Lidocaine). The
main indications for intra-articular corticosteroid injections into the
glenohumeral orthopedic practice are, capsulitis adhesiva or glenohumeral
osteoarthritis.
There are several approaches for injection in the glenohumeral joint. The
anterior and the posterior approach are the most common. In the Rijnland
Hospital, all injections are given through the posterior approach.
There is little evidence about the accuracy of such injection. The anterior
approach is most studied. In in-vivo studies, the results vary in accuracy of
26.8% to 96%. The posterior approach is less extensively studied. In the
literature, the results of this approach vary from 15% to 85%.
In addition, there is little literature on the correlation between the accuracy
and effectiveness of the glenohumeral injections. Hegedus-et-al showed no
correlation in 103 patients with various shoulder pathology between positive
results after a glenohumeral injection, and the accuracy or experience of the
giver.
Study objective
The primary purpose of this study is to prospectively evaluate the accuracy of
intra-articular glenohumeral injections via the posterior approach with
(incipient) adhesiva capsulitis (frozen shoulder). Furthermore the confidence
of the giver in a successful injection is tested.
The secondary objective is to demonstrate a relationship between the accuracy
and effectiveness of intra-articular injections.
Study design
After the diagnosis capsulitis adhesiva is made on the outpatient clinic, the
patient is enrolled. First they are asked to fill in the questionnaires, and an
X-ray is made to check if there are no other underlying problems.
Then follows the injection via the posterior approach. All injections within
this research are given by an experienced orthopedic surgeon with shoulder
pathology as subspecialty. After the injection the surgeon evaluates
(evaluation form (Appendix I)) if the intra-articular injection was placed
successful.
At the Department of Radiology, a radiograph is taken to assess whether the
contrast is actually injected intra-articular. The result is not communicated
to the patient.
The patient will be, as usual, seen at the outpatient clinic 6 and 12 weeks
after the injection. Then again the patient is requested to fill in the
questionnaires. Should the appointment at 6 weeks again indicate an injection,
the same procedure will be performed.
At the 12 week control moment the patient is announced if the contrast
injections were intra-articular.
Radiography
After the injection, an AP shoulder x-ray** is made. On this radiograph we can
distinguish whether the injection was intra-articular. An independent
radiologist reviewes whether the injection was successfully placed
intra-articular.
Study burden and risks
Allergic reaction from the contrast.
Prinsestraat 55
Den Haag 2513CB
NL
Prinsestraat 55
Den Haag 2513CB
NL
Listed location countries
Age
Inclusion criteria
Intra-articular corticoid injection is indicated with capsulitis adhesiva.
Exclusion criteria
-Known allergic reaction on Depomedrol, Lidocaine or contrast.
-Clinical signs of full thickness rotatorcuff rupture.
-Clinical signs of infection.
-Within 6 weeks after rotatorcuff repair operation.
-Pregnancy.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL42393.058.12 |