Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis (ESWT)
2026年8月9日 更新者: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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Shih-Wei Huang, MD
- 電話番号:+886970747556
- メール:shihwei@tmu.edu.tw
研究場所
-
-
Taipei
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Taipei、Taipei、台湾、116
- 募集
- Wan Fang Hospital, Taipei Medical University
-
コンタクト:
- Shih-Wei Huang
- 電話番号:0970747556
- メール:shihwei@tmu.edu.tw
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Ultrasound localization ESWT
Ultrasound image guided the depth and location of calcification point, Perform ESWT for calcific tendonitis of shoulder
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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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アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Constant-Murley Score (CMS)
時間枠: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)
時間枠: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.
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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 from Baseline in Shoulder Pain and Disability Index (SPADI)
時間枠:Baseline, Week 4, Week 12
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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.
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Baseline, Week 4, Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Calcific Deposit Resorption Rate
時間枠:Baseline, Week 4, Week 12
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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.
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Baseline, Week 4, Week 12
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Change from Baseline in Shoulder Range of Motion (ROM)
時間枠:Baseline, Week 4, Week 12
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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.
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Baseline, Week 4, Week 12
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Tendon Structural Integrity on Ultrasound
時間枠:Baseline, Week 4, Week 12
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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.
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Baseline, Week 4, Week 12
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Patient Global Impression of Change (PGIC)
時間枠:Week 4, Week 12
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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.
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Week 4, Week 12
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月30日
一次修了 (推定)
2027年4月30日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年8月5日
QC基準を満たした最初の提出物
2026年8月5日
最初の投稿 (実際)
2026年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月12日
QC基準を満たした最後の更新が送信されました
2026年8月9日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- N202604139
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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