- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07756307
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis (ESWT)
9 sierpnia 2026 zaktualizowane przez: Huang ShihWei, Taipei Medical University WanFang Hospital
Effectiveness of Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis of the Shoulder: A Randomized Double-Blind Controlled 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Shih-Wei Huang, MD
- Numer telefonu: +886970747556
- E-mail: shihwei@tmu.edu.tw
Lokalizacje studiów
-
-
Taipei
-
Taipei, Taipei, Tajwan, 116
- Rekrutacyjny
- Wan Fang Hospital, Taipei Medical University
-
Kontakt:
- Shih-Wei Huang
- Numer telefonu: 0970747556
- E-mail: shihwei@tmu.edu.tw
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Ultrasound localization ESWT
Ultrasound image guided the depth and location of calcification point, Perform ESWT for calcific tendonitis of shoulder
|
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
|
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Aktywny komparator: Palpation localization ESWT
Palpation and depends the feedback of participants localization of ESWT points
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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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Constant-Murley Score (CMS)
Ramy czasowe: 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.
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Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at Week 12)
|
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Change in Pain Visual Analog Scale (VAS)
Ramy czasowe: 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.
|
Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at Week 12)
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Change from Baseline in Shoulder Pain and Disability Index (SPADI)
Ramy czasowe: 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.
|
Baseline, Week 4, Week 12
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Calcific Deposit Resorption Rate
Ramy czasowe: 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.
|
Baseline, Week 4, Week 12
|
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Change from Baseline in Shoulder Range of Motion (ROM)
Ramy czasowe: 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.
|
Baseline, Week 4, Week 12
|
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Tendon Structural Integrity on Ultrasound
Ramy czasowe: 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.
|
Baseline, Week 4, Week 12
|
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Patient Global Impression of Change (PGIC)
Ramy czasowe: 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.
|
Week 4, Week 12
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
30 czerwca 2026
Zakończenie podstawowe (Szacowany)
30 kwietnia 2027
Ukończenie studiów (Szacowany)
31 sierpnia 2027
Daty rejestracji na studia
Pierwszy przesłany
5 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
10 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- N202604139
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
De-identified individual participant data (IPD) that underlie the results reported in the publication (including text, tables, figures, and appendices) will be shared.
This includes baseline characteristics, intervention adherence, and primary and secondary outcome measures.
Additionally, the study protocol, statistical analysis plan (SAP), and data dictionary will be made available.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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