Primary 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-…
ID
Bron
Verkorte titel
Aandoening
shoulder, rotator cuff, calcific, tendinopathy, treatment, shockwave, ESWT, barbotage, percutaneous needling, minimally invasive, schouder, tendinosis calcarea
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Constant Murley Score
Achtergrond van het onderzoek
In this randomized clinical trial patients with chronic calcific tendinopathy, not responding to a conservative treatment, will be allocated to either treatment with US-guided needling of high-energy shockwave therapy.
Doel van het onderzoek
Primary 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
Onderzoeksopzet
Follow-up: 6 wk, 3m, 6m, 1 year
Onderzoeksproduct en/of interventie
High-energy Extracorporeal Shockwave therapie (ESWT)
Ultrasound guided double percutaneous needling (Barbotage)
Publiek
Spaarne Ziekenhuis
Spaarnepoort 1
J.K.G. Louwerens
Hoofddorp 2134 TM
The Netherlands
0622129997
louwerej@spaarneziekenhuis.nl
Wetenschappelijk
Spaarne Ziekenhuis
Spaarnepoort 1
J.K.G. Louwerens
Hoofddorp 2134 TM
The Netherlands
0622129997
louwerej@spaarneziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4303 |
| NTR-old | NTR4448 |
| Ander register | NL44205.094.13 : M013-014 |