The Effect of Doppler Ultrasound on Calcified Tendinitis
NCT Number: NCT06503302
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Calcific Tendinitis of Shoulder
Interventions: DIAGNOSTIC_TEST: ultrasound Doppler function detection
Sponsor: Taipei Medical University Shuang Ho Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-10
Completion Date: 2025-12-31
Locations: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare, Taipei, 235, Taiwan

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.

Primary Outcome Measures: Need for a Second 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: Pain Index (Visual Analogue Scale, VAS), 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, 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, 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