Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis

NCT07756307 | Recruiting DMC

• 1 other identifier: N202604139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 wellestablished 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. We 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. We 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.

Conditions

Calcific Tendinitis of Shoulder

Keywords

Calcific tendonitis; shoulder; ultrasound; ESWT

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at Week 12)

• 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.

  Baseline, Week 4, and Week 12 after the start of treatment (primary endpoint at 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.

  Baseline, Week 4, Week 12

Secondary Outcomes (4)

• Calcific Deposit Resorption Rate

  Baseline, Week 4, Week 12

• Change from Baseline in Shoulder Range of Motion (ROM)

  Baseline, Week 4, Week 12

• Tendon Structural Integrity on Ultrasound

  Baseline, Week 4, Week 12

• Patient Global Impression of Change (PGIC)

  Week 4, Week 12

Study Arms (2)

Ultrasound localization ESWT

EXPERIMENTAL

Ultrasound image guided the depth and location of calcification point, Perform ESWT for calcific tendonitis of shoulder

Procedure: Ultrasound guide localization

Palpation localization ESWT

ACTIVE COMPARATOR

Palpation and depends the feedback of participants localization of ESWT points

Procedure: Palpation localization

Interventions

Ultrasound guide localization PROCEDURE

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

Ultrasound localization ESWT

Palpation localization PROCEDURE

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

Palpation localization ESWT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wan Fang Hospital, Taipei Medical University

Taipei, Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Central Study Contacts

Shih-Wei Huang, MD

CONTACT

+886970747556; shihwei@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)