The Effect of Doppler Ultrasound on Calcified Tendinitis

April 27, 2026 updated by: Taipei Medical University Shuang Ho Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 235
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).
between three days to one week after the initial ultrasound-guided injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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).
before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Hung-Chou Chen, Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-IJRB-N202311060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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