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The Effect of Doppler Ultrasound on Calcified Tendinitis

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06503302
Enrollment
100
Registered
2024-07-16
Start date
2024-07-10
Completion date
2026-06-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcific Tendinitis of Shoulder

Keywords

Doppler ultrasound

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.

Interventions

DIAGNOSTIC_TESTultrasound 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.

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Need for a Second Ultrasound-Guided Injectionbetween three days to one week after the initial ultrasound-guided injectionWhether 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

MeasureTime frameDescription
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 injectionA 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.
Size of Calcificationbefore treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injectionAssessed 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.
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnairebefore treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injectionQuickDASH 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).

Countries

Taiwan

Contacts

CONTACTMei Sean Loh
19210@s.tmu.edu.tw+886 02-22490088
PRINCIPAL_INVESTIGATORHung-Chou Chen

Taipei Medical University Shuang Ho Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026