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The Effect of Doppler Ultrasound on Calcified Tendinitis

No phase Interventional Calcific Tendinitis of Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound Doppler function detection.
Who it may be relevant to
Registry conditions: Calcific Tendinitis of Shoulder. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Doppler Ultrasound on Calcified Tendinitis: a Double Blind, Randomized Controlled Trial

Overview

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.

Interventions

  • Diagnostic test 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.

Primary outcome measures

  • Need for a Second Ultrasound-Guided Injection [Time frame: between three days to one week after the initial ultrasound-guided injection]
Secondary outcome measures (3)
  • Pain Index (Visual Analogue Scale, VAS) [Time frame: 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 [Time frame: 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 [Time frame: before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Taiwan · 1 center
  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare — Taipei

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06503302 · TMU-IJRB-N202311060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗