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Rotator Cuff Calcific Tendonitis: Needle US-guided treatment vs. Subacromial corticosteroids – A Randomized Controlled Trial.

Rotator Cuff Calcific Tendonitis: Needle US-guided treatment vs. Subacromial corticosteroids – A Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25749
Enrollment
80
Registered
2010-04-12
Start date
2010-02-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff calcific tendonitis Calcificerende tendinitis van de rotatoren manchet

Interventions

2 Usual care methods: 1. Group A: Ultrasound-guided barbotage treatment combined with subacromial corticosteroid injection
2. Group B: Ultrasound-guided treatment with subacromial corticosteroid injection.

Sponsors

Leiden University Medical Center, Leiden, the Netherlands Rijnland Hospital, Leiderdorp, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Calcifying tendonitis on x-rays ( 3 months); 4. Referred to orthopedics or radiology department for treatment; 5. Pain at night or after activities; 6. Worsening of complaints with elevation or abduction of the arm.

Exclusion criteria

Exclusion criteria: 1. Comorbidities of the affected shoulder (with physical examination, X-rays, US). Subacromial impingement syndrome is not an exclusion criterium; 2. >1 subacromial corticosteroid injections <3 months before eventual exclusion; 3. Previous barbotage treatment of the affected shoulder; 4. History of trauma or surgery on the affected shoulder; 5. Instability of the shoulder; 6. Frozen shoulder (<90 degrees of external rotation when in 90 degrees of abduction); 7. No informed consent.

Design outcomes

Primary

MeasureTime frame
Constant Shoulder Score (CS), measured at pre-intervention and at 6 weeks, 3 months, 6 months and 1 year after intervention.

Secondary

MeasureTime frame
Pre-intervention, and at 6 weeks, 3 months, 6 months and 1 year after treatment: 1. VAS-scores for pain during motion, pain at rest and shoulder function; 2. DASH-score; 3. RAND-36; 4. Western Ontario Rotator Cuff index. Pre-intervention: 1. Demographic data (duration of symptoms, gender, age, BMI, sports/employment); 2. Calcific depositions and location of these depositions on radiographs of the shoulder: Gärtner-classification. Immediately after intervention: 1. VAS-scores for pain during motion, pain at rest and shoulder function; 2. 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: 1. Presence of calcific depositions on standard radiographs (anteroposterior): Gärtner score.

Contacts

Public ContactP.B. Witte, de

PO Box 9600, postzone J-11-R

p.b.de_witte@lumc.nl+31 (0)71 5263606

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)