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ESWT vs Barbotage

A randomized clinical trial of ultrasound-guided double percutaneaous needling versus high-energy extracorporeal shockwave therapy in th treatment of calcific tendinopathy of the rotator cuff

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24831
Enrollment
100
Registered
2014-02-25
Start date
2014-03-01
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

shoulder, rotator cuff, calcific, tendinopathy, treatment, shockwave, ESWT, barbotage, percutaneous needling, minimally invasive, schouder, tendinosis calcarea

Interventions

High-energy Extracorporeal Shockwave therapie (ESWT) Ultrasound guided double percutaneous needling (Barbotage)

Sponsors

-
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 Clinical signs of subacromial pain of the Symptoms persisting for more than four Unsuccessful conservative therapy within the previous four months (Physiotherapy, radiotherapy, infiltration with local anaesthetics and/or steroids, anti-inflammatory drugs.) Standardised radiographs showing calcific deposits with a diameter of at least 5 mm o Morphological type-I and type-II deposits corresponding to the classification of Gartner and Simons on radiographs: Type I, sharply outlined and densely structured. Type II, sharply outlined and inhomogenous or homogenous with no defined border

Exclusion criteria

Exclusion criteria: Evidence of full thickness tears of the rotator cuff on physical examination, ultrasound images or MRI Radiological signs of spontaneous resorption of the deposit and type-III deposits according to the classification of Gartner and Simons: Type III, cloudy and transparent in structure Calcific deposits in multiple tendons of the rotator cuff Acute subacromial/subdeltoid bursitis Osteoarthritis of the glenohumeral or acromioclavicular joint Adhesive capsulitis Previous surgery to the shoulder Instability of the shoulder ESWT / barbotage within the last year Reumatoid arthritis Neurological disorders or dysfunction of the upper limb Heart pacemaker, pregnancy, infection, tumour, hypocoagulability Unability to give informed consent

Design outcomes

Primary

MeasureTime frame
Constant Murley Score

Secondary

MeasureTime frame
DASH, VAS (pain), VAS (satisfaction), complications, SF-12, work-ability questionnaire, change in radiographic morphology and size

Contacts

Public ContactJ.K.G. Louwerens

Department of orthopedic surgery Spaarne Ziekenhuis Spaarnepoort 1

louwerej@spaarneziekenhuis.nl0622129997

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)