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Rotator Cuff Calcific Tendonitis: Needle UltraSound-guided treatment vs. Subacromial corticosteroids: a randomized controlled trial

Rotator Cuff Calcific Tendonitis: Needle UltraSound-guided treatment vs. Subacromial corticosteroids: a randomized controlled trial - RCCT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32629
Enrollment
81
Registered
2010-02-16
Start date
2010-05-19
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

calcific deposits in the shoulder tendinosis calcarea

Interventions

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

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age: 18-65 years - diffuse lateral shoulder pain without improvement (> 3 months) - calcifying tendinitis on x-rays (

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)