Trial name or title |
Extracorporeal shock‐wave therapy for supraspinatus calcifying tendonitis: a randomized clinical trial comparing two different energy levels |
Methods |
Study design: Parallel, three‐arm, randomised controlled trial Setting: Shin Kong Wu Ho‐Su Memorial Hospital, Tapei, Taiwan Interventions: rESWT vs US‐guided needle puncture vs rESWT plus US‐guided needle puncture Analysis: not reported |
Participants |
Inclusion criteria:
Exclusion criteria:
pregnancy
clotting disorders
anticoagulant or antiplatelet treatment
cardiac pacemaker
chronic inflammatory joint disease
infections or tumours of the shoulder
adhesive capsulitis
hyperalgia of the shoulder due to resorption of a calcific deposit
calcification of type III as defined by Gärtner or nodular or cystic type of calcification defined by Chiou
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Interventions |
rESWT:
description of modality used: rESWT
dose: an energy level of 0.26 mJ/mm², 2000 shock waves at 2 Hz
frequency: once per week, for 3 weeks
any additional treatment during trial: NA
US‐guided needle puncture:
dose: 3 mL 1% xylocaine
method of administration: all needle punctures will be guided by US. The puncture needle is a 3.8 cm 22‐gauge needle attached on a 5 mL syringe. Before puncture, the skin of the puncture site will be sterilised with iodine, and the transducer will be covered with a sterilised plastic bag. After injecting 3 mL 1% xylocaine in subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back‐and‐forth puncture about 10–20 times (depending on the size of the plaques) within the calcific plaques will be performed. The needle tract will be monitored by US to make sure the needle penetrated through the calcific plaque, but does not penetrate the rotator cuff
frequency: single treatment
rESWT plus US‐guided needle puncture:
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Outcomes |
Outcomes included in review:
pain (VAS) (6 weeks, 3 months after treatment)
active ROM and passive ROM (6 weeks, 3 months after treatment)
quality of life: general health status: SF–36 (6 weeks, 3 months after treatment)
treatment success: participant satisfaction (6 weeks, 3 months after treatment)
Outcomes excluded from review:
|
Starting date |
April 2013 |
Contact information |
Lin‐Fen Hsieh, MD, Shin Kong Wu Ho‐Su Memorial Hospital |
Notes |
Estimated completion date: study completed, no results posted Trial registration: ClinicalTrials.gov identifier NCT02677103. Status on 9 May 2018: recruitment completed, 61 participants enrolled, no study results available. Last update posted on 25 March 2016 on the ClinicalTrials.gov website. |