NTR7093.

Trial name or title	Needle aspiration of calcific deposits versus extracorporeal shock wave therapy for conservative therapy resistant calcifying tendinitis of the shoulder
Methods	Study design: parallel, two‐arm, randomised controlled trial Setting: Maxima Medical Centre, Netherlands Interventions: needle aspiration of calcific deposits vs ESWT Analysis: not reported
Participants	Inclusion criteria: aged > 18 years chronic shoulder complaints > 6 months calcifications on conventional X‐rays: type I and II calcifications according to the Gärtner classification; minimal diameter of calcification of 10 mm on anteroposterior view able and willing to comply to study protocol Exclusion criteria: clinical signs of a frozen shoulder or adhesive capsulitis history of operations of the affected shoulder needle aspiration of calcific deposits or ESWT during last 6 months clinical and radiological signs of acute subacromial bursitis full‐thickness lesion of the rotator cuff tendon(s) on sonography clinical and radiological signs of acromioclavicular osteoarthritis rheumatic arthritis or fibromyalgia other intra‐articular pathology: cartilage lesions, biceps pathology any contraindication for the specific treatments (e.g. coagulopathies, malignancies in treated area
Interventions	Needle aspiration of calcific deposits: sonographically guided removal of the calcific deposits will be performed ESWT: participants will receive a focused ESWT Both procedures will be conducted according to a standardised protocol
Outcomes	Outcomes included in review: recovery of functional outcome score of the Constant Score (baseline to 12 months) pain scores (baseline to 12 months) quality of life scores (baseline to 12 months) medication use and adverse events (12 months) Outcomes excluded from review: cost‐effectiveness the 'Diagnose & Behandel Combinatie (DBC)' to find a difference in procedural costs of the 2 treatment modalities
Starting date	1 April 2018
Contact information	Dr Max Reijman PhD, Maxima Medical Centre, Netherlands
Notes	Estimated completion date: 1 January 2021 Trial registration: NTR7093. Status on 8 May 2018, recruitment not yet commenced.