Clinical trial NCT01538758: Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.
Official title: Treatment of Calcifying Tendinitis of the Shoulder: Ultrasound Guided Needling With Subacromial Corticosteroid Injection Versus Ultrasound Guided Subacromial Corticosteroid Injection Only, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calcific Tendinitis
Keywords: calcifying tendinitis
rotator cuff
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

Detailed description: Calcifying tendinitis of the shoulder is a common cause of shoulder pain with an incidence ranging from 2.7 % to 6.8 %. This disease of the rotator cuff tendons is characterised by calcifications in the tendons, most commonly in the supraspinatus tendon up to 82%. The aetiology remains unclear.

Calcifying tendinitis is regarded as a self-healing condition with usually spontaneous resolution of the calcifications. But some patients have chronic or recurrent pain and disability of the shoulder which requires treatment. The treatment should be minimally invasive and effective in short and long term. Symptomatic treatment is indicated first using non-steroidal anti-inflammatory drugs, therapeutic exercise and non ultrasound guided subacromial corticosteroids injection.

The role of corticosteroid injections is unknown due to the lack of good studies. Family doctors and orthopaedic surgeons inject corticosteroids in the shoulder without the guidance of ultrasound; with this method accurate needle placement in the subacromial bursa is not possible. When this treatment fails other therapeutical methods can be used. Ultrasound guided needling is a percutaneous technique of fragmentation or extraction of calcifications in the rotator cuff tendon.

Literature shows favourable results but only a few randomized controlled trials were executed. Randomised controlled trials are needed to give more insight in the effectiveness of us guided needling. Comparing two groups of patients treated with us guided corticosteroid injection and one group combined with us guided needling can provide information of the usefulness of us guided needling.

Eligibility criteria: Inclusion Criteria:

* Shoulder pain without improvement after 3 months despite conservative treatment
* Calcification on x-ray (Gartner 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

Exclusion Criteria:

* Previous operation of the shoulder
* Previous ultrasound guided needling of the shoulder
* Frozen shoulder
* Last corticosteroid injection less than 3 months ago
* Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)
* No informed consent
* Pregnancy

Primary outcomes:
measure: VAS score on long term
timeFrame: 1 year
measure: Constant score on long term
timeFrame: 1 year
Secondary outcomes:
measure: Constant score
timeFrame: baseline,6 weeks, 3 months and 6 months
measure: VAS score
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months and 6 months
measure: DASH score
timeFrame: baseline, 6 weeks, 3 months, 6 months and 1 year.
measure: Gärtner score of the shoulder calcifications on x-ray
timeFrame: at baseline, directly post-interventional, at 6 weeks and one year.
measure: Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound
timeFrame: at baseline, directly post-interventional, at 6 weeks and one year.
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: MST
name: Eva Genbrugge, MD
role: PRINCIPAL_INVESTIGATOR
References: