Authors
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Taipei Medical University WanFang Hospital -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
»
2026
Calcific tendinitis of the shoulder is a debilitating musculoskeletal condition thatsignificantly impacts the working‐age population, typically those between 30 and 60 yearsof age. Accounting for approximately 7‐ 17% of shoulder pain complaints, it ischaracterized by the pathological deposition of calcium hydroxyapatite crystals withinthe rotator cuff tendons, most notably the supraspinatus. The progression of the disease,particularly during the resorptive phase described in Uhthoff's cycle, is associated witha dramatic increase in intratendinous pressure and severe inflammatory pain, leading tosubstantial functional impairment and socioeconomic burden. While Extracorporeal ShockWave Therapy (ESWT) is a well established non‐invasive modality known to promote calcificresorption via cavitation effects and mechanotransduction‐induced neovascularization, itsclinical efficacy remains highly variable across current literature, with success ratesranging widely from 47% to 87%. This inconsistency is largely attributed to thelimitations inherent in conventional "blind" or landmark‐based targeting techniques.Given that calcific deposits are often small, deeply situated, or obscured by theacromion, palpation‐guided targeting is frequently unreliable, resulting in suboptimalenergy delivery to the pathology and potential collateral damage to surrounding healthytissues. This one‐year research project aims to evaluate the superior efficacy of"Real‐time Ultrasound‐Guided" ESWT compared to conventional methods. The investigatorspropose a prospective, randomized, double‐blind, controlled trial (RCT) that will recruit60 patients with confirmed calcific tendinitis. Participants will be stratified byGärtner classification (Type I‐III) to ensure balanced morphological distribution andthen randomized into either an experimental group receiving Ultrasound‐Guided FocusedESWT or a control group receiving Landmark‐based/Sham ESWT. The study incorporatesrigorous methodology, including a priori power analysis for sample size estimation,strict allocation concealment, and assessor blinding. Outcomes will be assessed atbaseline, 4, and 12 weeks post‐treatment. Primary outcomes include the Constant‐MurleyScore (CMS) and Visual Analog Scale (VAS), while secondary outcomes involve quantitativeultrasound analysis using ImageJ software to measure the reduction in calcific depositvolume and assess tendon integrity. The investigators hypothesize that the integration ofrealtime ultrasound guidance will significantly enhance therapeutic precision, leading tohigher rates of calcific resorption and functional recovery. The findings are expected toprovide high‐level evidence to standardize ESWT protocols, thereby advancing theimplementation of precision medicine in the field of physical and rehabilitationmedicine.
Epistemonikos ID: 090956397d134e7ec297f02e3a6e04c1e8390d39
First added on: Aug 11, 2026