To compare the mid-term results (4-5 years) of ultrasound-guided barbotage combined with subacromial corticosteroid injections vs. ultrasound-guided subacromial corticosteroid injections alone, in patients with calcifying tendinitis, enrolled in the…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mid-term Constant Score (4-5 years).
Secondary outcome
WORC, DASH, VAS scores for pain, anchor questions, aspect, location and
classification (including Gärtner score) of eventual calcifications and the
state of the rotator cuff (e.g. tendonitis or rupture y/n).
Background summary
Calcifying tendinitis (CAT) of the shoulder is frequently diagnosed in case of
shoulder pain. CAT is generally considered to be a self-limiting condition, but
symptoms can be very severe and long-lasting. Therefore, there is much debate
on the treatment of CaT, and on the use of more or less invasive treatment
methods.
In 2013, we published the results of a trial comparing two common treatments of
CaT, with a follow-up period of 1 year (P09.239, Am J Sports Med 2013 Jul; 41
(7):. 1665-73): ultrasound-guided needling and lavage (barbotage) combined with
subacromial corticosteroid injections vs. ultrasound-guided subacromial
corticosteroid injections.
The results showed, that there was clinical and radiological progress in both
treatment groups after 1 year of follow-up. However, both the clinical and
radiological results of barbotage were significantly better.
This was the first trial in which these common treatment methods were compared.
However, for both treatments, long-term results are unclear, as for most other
treatments of CAT.
Study objective
To compare the mid-term results (4-5 years) of ultrasound-guided barbotage
combined with subacromial corticosteroid injections vs. ultrasound-guided
subacromial corticosteroid injections alone, in patients with calcifying
tendinitis, enrolled in the RCCT trial in 2010-2011.
Study design
Randomized controlled trial (RCT), double-blinded, mid-term results. Level of
evidence: II.
Study burden and risks
Participation in this study takes each subject 60 minutes of time. Subjects
will undergo an X-ray (exposure to ± 0.02 mSv/X-ray-shoulder).
Subjects will have no direct benefit from participating in this study.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Included in original RCCT trial (P09.239)
Exclusion criteria
none
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 | NL53922.058.15 |