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ESWT vs Barbotage


- candidate number16553
- NTR NumberNTR4448
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2014
- Secondary IDsM013-014 NL44205.094.13
- Public TitleESWT vs Barbotage
- Scientific TitleA 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
- ACRONYMKALK
- hypothesisPrimary Objective: The primary objective of this study is to evaluate the difference in functional outcome, measured by the Constant Murley Scale at six weeks, three months, six months and one year, after treatment with high-energy ESWT versus US-guided double needle percutaneous barbotage for calcific tendinopathy of the rotator cuff. Secondary Objective(s): The secondary objective is to evaluate the difference in the secondary outcome measures after treatment with high-energy ESWT versus US-guided double needle percutaneous barbotage for calcific tendinopathy of the rotator cuff. Secondary outcome measures VAS (pain) scale VAS (satisfaction) scale SF-12 Work ability questionnaire DASH The presence and size of calcific deposits on conventional radiography
- Healt Condition(s) or Problem(s) studiedShoulder disorders , Tendinopathy, Rotator cuff, Shockwave therapy, Calcific tendonitis, Barbotage
- Inclusion criteriaAge > 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 criteriaEvidence 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-sep-2016
- Target number of participants100
- InterventionsHigh-energy Extracorporeal Shockwave therapie (ESWT) Ultrasound guided double percutaneous needling (Barbotage)
- Primary outcomeConstant Murley Score
- Secondary outcomeDASH, VAS (pain), VAS (satisfaction), complications, SF-12, work-ability questionnaire, change in radio graphic morphology and size
- TimepointsFollow-up: 6 wk, 3m, 6m, 1 year
- Trial web sitewww.wetenschapsbureau.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.K.G. Louwerens
- CONTACT for SCIENTIFIC QUERIES J.K.G. Louwerens
- Sponsor/Initiator Spaarne Hospital
- Funding
(Source(s) of Monetary or Material Support)
Spaarne Hospital, Richard Wolf GmbH
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-feb-2014 - 8-apr-2014


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