Calcific Tendinitis of Shoulder
Conditions
Keywords
Calcific tendonitis, shoulder, ultrasound, ESWT
Brief summary
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.
Interventions
PROCEDUREUltrasound guide localization
Use 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
PROCEDUREPalpation localization
Use palpation localization of calcific tendonitis of shoulder and then perform Extracorporeal Shock Wave Therapy, ESWT 0.12 to 0.25 mJ/mm 6000 times
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Baseline self-reported pain intensity greater than 4 on the Visual Analog Scale (VAS, 0-10) * Willing and able to provide written informed consent
Exclusion criteria
* 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 * Malignancy, particularly involving or adjacent to the shoulder region * Local infection or skin lesion at the intended treatment site * Injection therapy to the ipsilateral shoulder within the preceding 6 weeks * Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Constant-Murley Score (CMS) | Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at Week 12) | 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) | Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at Week 12) | 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) | Baseline, Week 4, Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Calcific Deposit Resorption Rate | Baseline, Week 4, Week 12 | 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) | Baseline, Week 4, Week 12 | 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 | Baseline, Week 4, Week 12 | 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) | Week 4, Week 12 | 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. |
Countries
Taiwan
Contacts
CONTACTShih-Wei Huang, MD
Outcome results
None listed