The Effect of Doppler Ultrasound on Calcified Tendinitis

NCT06503302 | Recruiting

• 1 other identifier: TMU-IJRB-N202311060
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Calcific tendinitis of the shoulder, is a self-limiting disease characterized by the deposition of calcium phosphate crystals in the rotator cuff tendons. Patients will develop complications such as decreased range of motion of the shoulder joint, and thus reducing their quality of life. The most common site of occurrence is 1.5-2 cm away from the supraspinatus tendon insertion site on the greater tuberosity. The primary treatment for calcific tendinitis is conservative, such as non-steroidal anti-inflammatory analgesics for pain relieving, extracorporeal shock wave therapy, subacromial steroid injections, ultrasound-guided barbotage technique for aspirating and washing out calcific deposits. Ultrasound is being used in calcified tendinitis for evaluating its size, location, quality, and also using the color Doppler ultrasonography to evaluate its reactive inflammatory changes. However, the use of color Doppler ultrasonography in diagnosing and treating a shoulder pain with calcification is not being concluded yet. Therefore, the aim of this study is to evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.

Conditions

Calcific Tendinitis of Shoulder

Keywords

Doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• Need for a Second Ultrasound-Guided Injection

  Whether a second ultrasound-guided injection is needed within a short period after the initial ultrasound-guided treatment, meaning whether significant improvement can be rapidly achieved after the first ultrasound-guided injection (defined as a reduction in pain index ≥50%).

  between three days to one week after the initial ultrasound-guided injection

Secondary Outcomes (3)

• Pain Index (Visual Analogue Scale, VAS)

  before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection

• Size of Calcification

  before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection

• Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire

  before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection

Study Arms (2)

With Doppler ultrasound

EXPERIMENTAL

The physician will use Doppler function detection to check if calcifications are under active inflammation before ultrasound-guided injection.

Diagnostic Test: ultrasound Doppler function detection

Without Doppler ultrasound

ACTIVE COMPARATOR

The physician will only open the Doppler image in the non-calcified area for patient blinding before the ultrasound-guided injection.

Diagnostic Test: ultrasound Doppler function detection

Interventions

ultrasound Doppler function detection DIAGNOSTIC_TEST

Doppler function detection is an ultrasound technique that measures and visualizes blood flow within an object, such as vessels and soft tissue. It can be used to check for the inflammation status of calcifications by detecting blood flow around the calcified areas before performing an ultrasound-guided injection.

With Doppler ultrasound; Without Doppler ultrasound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic shoulder pain for more than 1 month
• shoulder X-ray showed calcified deposit

You may not qualify if:

• patient with needle phobia
• patient with known allergy to medication like Triamcinolone and Lidocaine

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

Taipei, 235, Taiwan

RECRUITING

Related Publications (5)

• Janeiro J, Barreira SC, Martins P, Ninitas P, Campos J, Fonseca JE. Ultrasound Features Associated With Shoulder Complaints: Calcifications Larger Than 6 mm in Young Patients and Positive Doppler Are Associated With Pain. Front Med (Lausanne). 2021 Nov 19;8:715423. doi: 10.3389/fmed.2021.715423. eCollection 2021.

  PMID: 34869414 BACKGROUND

• Janeiro J, Barreira S, Martins P, Sarmento M, Campos J, Fonseca JE. Ultrasound findings and prognosis of shoulder pain: A role for Doppler signal? J Clin Ultrasound. 2023 Jun;51(5):837-844. doi: 10.1002/jcu.23436. Epub 2023 Jan 30.

  PMID: 36715681 BACKGROUND

• Cesarec G, Martinec S, Cicak N. CALCIFIC TENDINOPATHY: CALCIUM DEPOSIT MORPHOLOGY DIRECTLY AFFECTS PAIN AND FUNCTION OF THE SHOULDER. Acta Clin Croat. 2020 Jun;59(2):270-276. doi: 10.20471/acc.2020.59.02.10.

  PMID: 33456114 BACKGROUND

• Bazzocchi A, Pelotti P, Serraino S, Battaglia M, Bettelli G, Fusaro I, Guglielmi G, Rotini R, Albisinni U. Ultrasound imaging-guided percutaneous treatment of rotator cuff calcific tendinitis: success in short-term outcome. Br J Radiol. 2016;89(1057):20150407. doi: 10.1259/bjr.20150407. Epub 2015 Nov 26.

  PMID: 26607641 BACKGROUND

• Patil P, Dasgupta B. Role of diagnostic ultrasound in the assessment of musculoskeletal diseases. Ther Adv Musculoskelet Dis. 2012 Oct;4(5):341-55. doi: 10.1177/1759720X12442112.

  PMID: 23024711 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Hung-Chou Chen

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Sean Loh

CONTACT

+886 02-22490088; 19210@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: July 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)