The Effect of Doppler Ultrasound on Calcified Tendinitis

NCT ID: NCT06503302

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-12-31

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.

Detailed Description

Purpose: To evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.

Conditions

Calcific Tendinitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

With Doppler ultrasound

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

Group Type: EXPERIMENTAL

ultrasound Doppler function detection

Intervention Type: 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.

Without Doppler ultrasound

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

Group Type: ACTIVE_COMPARATOR

ultrasound Doppler function detection

Intervention Type: 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.

Interventions

ultrasound Doppler function detection

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. chronic shoulder pain for more than 1 month

2. shoulder X-ray showed calcified deposit

Exclusion Criteria

1. patient with needle phobia

2. patient with known allergy to medication like Triamcinolone and Lidocaine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Chou Chen

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Mei Sean Loh

Role: CONTACT

19210@s.tmu.edu.tw

+886 02-22490088 ext. 1603

Facility Contacts

Mei-Sean Loh

Role: primary

19210@s.tmu.edu.tw

+886 02-22490088 ext. 1603

References

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.

Reference Type: BACKGROUND

PMID: 34869414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36715681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33456114 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26607641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23024711 (View on PubMed)

Other Identifiers

TMU-IJRB-N202311060

Identifier Type: -

Identifier Source: org_study_id