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NCT Number: NCT06503302

The Effect of Doppler Ultrasound on Calcified Tendinitis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, 235, Taiwan

Location status: Recruiting

Location contact

Mei-Sean Loh

CONTACT

[email protected]

+886 02-22490088 ext. 1603

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Need for a Second Ultrasound-Guided Injection

    Time frame: between three days to one week after the initial 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%).

Secondary outcomes

  1. 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

    A simple and quick assessment method using a numerical scale from 0 to 10, where "0" represents no pain at all and "10" represents the most unbearable pain. The participant rates their own pain level.

  2. 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

    Assessed using shoulder X-rays. The principal investigator will prescribe shoulder X-rays in the anteroposterior and lateral views during clinic visits. An outcome assessor will measure the calcification three times in each direction and calculate the average of the three measurements. The larger area from the two directions will be taken as the final measurement result.

  3. 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

    QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb. It also consists of two optional modules: high-level sports/performing arts and work modules (4 items each, scored from 1 to 5).

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Sean Loh

CONTACT

[email protected]

+886 02-22490088 ext. 1603

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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