The Effect of Doppler Ultrasound on Calcified Tendinitis

Not Applicable

Recruiting

• Conditions: Calcific Tendinitis of Shoulder
• Interventions: Diagnostic Test: ultrasound Doppler function detection

• Registration Number: NCT06503302
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-10
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Doppler ultrasound	ultrasound Doppler function detection	The physician will use Doppler function detection to check if calcifications are under active inflammation before ultrasound-guided injection.
Without Doppler ultrasound	ultrasound Doppler function detection	The physician will only open the Doppler image in the non-calcified area for patient blinding before the ultrasound-guided injection.

Primary Outcome Measures

Name	Time	Method
Need for a Second Ultrasound-Guided Injection	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 Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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).

Trial Locations

Locations (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare; 🇨🇳 Taipei, Taiwan