About this trial
Calcific tendinitis of the shoulder is a debilitating musculoskeletal condition that significantly impacts the working-age population, typically those between 30 and 60 years of age. Accounting for approximately 7- 17% of shoulder pain complaints, it is characterized by the pathological deposition of calcium hydroxyapatite crystals within the rotator cuff tendons, most notably the supraspinatus. The progression of the disease, particularly during the resorptive phase described in Uhthoff's cycle, is associated with a dramatic increase in intratendinous pressure and severe inflammatory pain, leading to substantial functional impairment and socioeconomic burden. While Extracorporeal Shock Wave Therapy (ESWT) is a well established non-invasive modality known to promote calcific resorption via cavitation effects and mechanotransduction-induced neovascularization, its clinical efficacy remains highly variable across current literature, with success rates ranging widely from 47% to 87%. This inconsistency is largely attributed to the limitations inherent in conventional "blind" or landmark-based targeting techniques. Given that calcific deposits are often small, deeply situated, or obscured by the acromion, palpation-guided targeting is frequently unreliable, resulting in suboptimal energy delivery to the pathology and potential collateral damage to surrounding healthy tissues. This one-year research project aims to evaluate the superior efficacy of "Real-time Ultrasound-Guided" ESWT compared to conventional methods. The investigators propose a prospective, randomized, double-blind, controlled trial (RCT) that will recruit 60 patients with confirmed calcific tendinitis. Participants will be stratified by Gärtner classification (Type I-III) to ensure balanced morphological distribution and then randomized into either an experimental group receiving Ultrasound-Guided Focused ESWT or a control group receiving Landmark-based/Sham ESWT. The study incorporates rigorous methodology, including a priori power analysis for sample size estimation, strict allocation concealment, and assessor blinding. Outcomes will be assessed at baseline, 4, and 12 weeks post-treatment. Primary outcomes include the Constant-Murley Score (CMS) and Visual Analog Scale (VAS), while secondary outcomes involve quantitative ultrasound analysis using ImageJ software to measure the reduction in calcific deposit volume and assess tendon integrity. The investigators hypothesize that the integration of realtime ultrasound guidance will significantly enhance therapeutic precision, leading to higher rates of calcific resorption and functional recovery. The findings are expected to provide high-level evidence to standardize ESWT protocols, thereby advancing the implementation of precision medicine in the field of physical and rehabilitation medicine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 20 and 70 years
Unilateral calcific tendinitis of the shoulder confirmed by clinical physical examination, including a positive Neer's impingement test
Symptom duration of more than 3 months
Imaging (radiography and/or high-resolution ultrasound) demonstrating a calcific deposit within a rotator cuff tendon with a maximal diameter greater than 5 mm
Disqualifiers
Concomitant full-thickness rotator cuff tear
History of fracture or surgery involving the ipsilateral shoulder
Coagulopathy, or anticoagulant therapy that cannot be safely discontinued
Pregnancy or breastfeeding
Trial design
Parallel
Treatments tested in this trial
Ultrasound guide localization
Procedure/SurgeryUse ultrasound guided localization of calcific tendonitis of shoulder and then perform Extracorporeal Shock Wave Therapy, ESWT 0.12 to 0.25 mJ/mm 6000 times
Palpation localization
Procedure/SurgeryUse palpation localization of calcific tendonitis of shoulder and then perform Extracorporeal Shock Wave Therapy, ESWT 0.12 to 0.25 mJ/mm 6000 times
Treatment groups
Trial outcomes
Primary outcomes
Change in Constant-Murley Score (CMS)
The Constant-Murley Score is a clinician-administered instrument assessing shoulder function across four domains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and strength (25 points), for a total score of 0-100. Higher scores indicate better shoulder function. The measure compares real-time high-resolution ultrasound-guided focused ESWT (experimental) with X-ray plus palpation-guided focused ESWT (control) for calcific tendinitis of the shoulder. Assessed at baseline, Week 4, and Week 12; change from baseline is reported.
Change in Pain Visual Analog Scale (VAS)
Pain intensity is self-reported on a 0-10 Visual Analog Scale, where 0 = no pain and 10 = worst imaginable pain. Ratings are collected for pain at rest, pain with activity, night pain, and average pain over the past week. Higher scores indicate greater pain. Change from baseline is compared between the ultrasound-guided ESWT and landmark (X-ray + palpation)-guided ESWT groups. Assessed at baseline, Week 4, and Week 12.
Change from Baseline in Shoulder Pain and Disability Index (SPADI)
Patient-reported questionnaire comprising a 5-item pain subscale and an 8-item disability subscale, each item scored 0-10. Subscale and total scores are expressed as percentages (0-100%), with higher scores indicating greater pain and disability.
Secondary outcomes
Calcific Deposit Resorption Rate
Calcific deposit dimensions (long axis, short axis, area, and estimated volume) are quantified from ultrasound images using ImageJ software. Percentage volume reduction from baseline is calculated. Resorption is additionally categorized as complete, partial (\>50%), partial (\<50%), unchanged, or increased.
Change from Baseline in Shoulder Range of Motion (ROM)
Active and passive range of motion measured in degrees with a goniometer for forward flexion, abduction, external rotation at 90° abduction, and internal rotation at 90° abduction.
Tendon Structural Integrity on Ultrasound
Supraspinatus (or affected) tendon integrity graded on high-resolution ultrasound as intact, partial-thickness tear, or full-thickness tear. Tendon thickness is recorded in millimeters.
Patient Global Impression of Change (PGIC)
Single-item 7-point scale ranging from 1 (very much improved) to 7 (very much worse), capturing the participant's overall perceived change since starting treatment.
Locations
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Sponsors and contacts
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