To compare short (6 weeks, 3 months) and longer term (6 months, 1 year) results of ultrasound-guided barbotage treatment combined with subacromial corticosteroid injection treatment, versus ultrasound-guided treatment with subacromial…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pre-intervention and at 6 weeks, 3 months, 6 months and 1 year after
intervention:
- Constant Shoulder Score (CS).
Secondary outcome
Pre-intervention, and at 6 weeks, 3 months, 6 months and 1 year after treatment:
- VAS-scores for pain during motion, pain at rest and shoulder function.
- DASH-score
- RAND-36.
- Western Ontario Rotator Cuff index
Pre-intervention:
- Demographic data (duration of symptoms, gender, age, BMI, sports/employment).
- Calcific depositions and location of these depositions on radiographs of the
shoulder: Gärtner-classification.
Immediately after intervention:
- VAS-scores for pain during motion, pain at rest and shoulder function.
- Barbotage Score form: signs of bursitis, other shoulder injuries
(impingement, acromioclavicular osteoarthritis, rotator cuff ruptures),
substantion of the calcific depositions (hard, pulver, viscous), aspiration
(yes/no), perforation (yes/no), location of calcific depostions.
Immediately after intervention, 6 weeks, and 1 year after intervention
- Presence of calcific depositions on standard radiographs (anteroposterior):
Gärtner score.
Background summary
Calcifying tendinitis (CAT) of the shoulder is frequently diagnosed in case of
shoulder complaints. It is a self-limiting disease, but there is much
discussion about whether or not to treat CaT and which treatment methods can be
applied.
Recently, in the *Medisch Contact* journal, it was stated that
ultrasound-guided needle treatment for CaT (barbotage) is more effective than
conservative treatment methods in patients diagnosed with CaT. This conclusion
was based on a recent article of Serafini et al. in *Radiology*: a
non-randomized trial in which patients were treated with barbotage in
combination with subacromial corticosteroid injections. However, treatment and
inclusion criteria of the control group were unclear.
A randomized controlled trial, in which both the patient and the control group
are treated with subacromial corticosteroid injections, would provide more
insight in the effectiveness of barbotage-treatment in patients with CaT.
Study objective
To compare short (6 weeks, 3 months) and longer term (6 months, 1 year) results
of ultrasound-guided barbotage treatment combined with subacromial
corticosteroid injection treatment, versus ultrasound-guided treatment with
subacromial corticosteroids injection, in patients with calcificerende
calcific.
Study design
Randomized controlled trial, double blinded
Intervention
2 Usual care methods:
Group A: ultrasound-guided barbotage treatment combined with subacromial
corticosteroid injection.
Group B: ultrasound-guided treatment with subacromial corticosteroid injection.
Study burden and risks
2 Usual care pathways are compared. In addition: randomization, 2 additional
radiographs, filling out questionnaires and an additional follow-up visit.
--> Usual care--> no additional risks (low infection risk in both injection-
and barbotage-treatment)
2 additional radiographs
Little additional risks compared to usual care, but the gaining of knowledge
about frequently applied treatments of CaT. Furthermore, subjection to
additional diagnostics and more contacts/visits to the doctor are a result of
participation in the study.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
- Age: 18-65 years
- diffuse lateral shoulder pain without improvement (> 3 months)
- calcifying tendinitis on x-rays (< 6 weeks before eventual inclusion)
- referred to orthopedics or radiology department for treatment
- pain at night or after activities
- worsening of complaints with elevation or abduction of the arm
Exclusion criteria
- Comoribidities of the affected shoulder (with physical examination, X-rays, US). Subacromial impingement syndrome is not an exclusion criterium.
- >1 subacromial corticosteroid injections <3 months before eventual exclusion.
- previous barbotage treatment of the affected shoulder
- history of trauma or surgery on the affected shoulder
- instability of the shoulder
- frozen shoulder (<90 degrees of external rotation when in 90 degrees of abduction)
- no informed consent
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 | NL30845.058.09 |