To compare long term outcome of patients with calcifying tendinitis of the rotator cuff treated with us guided needling with us guided cortocosteroids injection versus us guided cortocosteroids injection only. .
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare long term outcome of patients with calcifying tendinitis of the
rotator cuff treated with us guided needling with us guided cortocosteroids
injection versus us guided cortocosteroids injection only. The primary endpoint
is VAS and Contstant scores at 1 year.
Secondary outcome
To get an insight in shoulder disability in daily life DASH score will be
measured at baseline, 6 weeks, 3 months, 6 months and 1 year.
VAS and Constant score at baseline, 6 weeks, 3 and 6 months.
Sometimes patients have heavy pain very shortly after us guided needling. Vas
score will be taken after two weeks.
The reaction of the calcifications of the rotator cuff tendons on the executed
therapy will be measured on x-ray and ultrasound of the shoulder using Gärtner
score on x-ray and a scoring system presented by Chiou et all. on ultrasound.
The measurements will be made directly post-interventionial, at 6 weeks and one
year.
Background summary
Us guided needling is becoming an accepted treatment for patients with shoulder
pain due to calcifying tendinitis. However, evidence for this treatment is
lacking. We expect that patients treated with us guided needling with
corticosteroid injection compared with patients treated with only
corticosteroid injections have better clinical outcome after after one year
follow-up.
Study objective
To compare long term outcome of patients with calcifying tendinitis of the
rotator cuff treated with us guided needling with us guided cortocosteroids
injection versus us guided cortocosteroids injection only. .
Study design
randomized controlled trial
Intervention
Us guided needling with us guided subacromial corticosteroid injection or us
guided subacromial corticosteroid injection alone.
Study burden and risks
Both interventions are standard accepted therapies. There are no additional
risks for patients included in this trial.
Haaksbergerstraat 55
7513ER Enschede
NL
Haaksbergerstraat 55
7513ER Enschede
NL
Listed location countries
Age
Inclusion criteria
-Shoulder pain without improvement after 3 months despite conservative treatment
-Calcification on x-ray ( Gärtner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment
-All patients are first seen and included by the orthopaedic surgeon
-Last corticosteroid injection more than 3 months ago
Exclusion criteria
-Previous operation
- previous ultrasound guided needling of the shoulder
-Frozen shoulder
-Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)
-No informed consent
-Pregnancy
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT01538758 |
| CCMO | NL38178.044.11 |