Clinical trial NCT05272085: Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis
Official title: Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcific Tendinitis
Calcific Tendinitis of Shoulder
Shoulder Pain
Keywords: Calcific tendinitis
Shoulder pain
Ultrasound-guided
Lavage
Barbotage
subacromial bursa injection
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is aimed to compare in the early period the clinical and ultrasonographic findings in terms of the effectiveness of ultrasound-guided subacromial bursa injection with corticosteroid and ultrasound-guided lavage, which are the treatment options available in the literature for patients with calcific tendinitis who do not respond to conservative treatment.

Detailed description: Calcific tendinitis is a disease that occurs with the precipitation of hydroxyapatite crystals on tendons and shoulder region is the most involved. In the shoulder region, calcific tendinitis can involve all rotator cuff tendons, most commonly the supraspinatus. It may progress with pain and functional limitation. The pain can increase with movement or can occur at rest and sleep. The prevalence of calcific tendinitis is between 2.7% and 20% in the general population. The most common age group is between 30 and 60. It can negatively affect the family and social life of the person and cause loss of workforce.

Especially in the treatment of patients with calcific tendinitis unresponsive to conservative treatment, ultrasound-guided corticosteroid injection in subacromial bursa and ultrasound-guided lavage are frequently used treatment options. However, there are very few studies in the literature comparing these two treatment methods as randomized controlled trials.

In this study, it is aimed to compare the effectiveness of ultrasound guided subacromial bursa injection and ultrasound guided lavage procedures on pain scores, functional scales, disability scales, direct radiography findings and ultrasonographic imaging findings.

Eligibility criteria: Inclusion Criteria:

* Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment
* Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging
* Cases between the ages of 18-75 whose informed consent was obtained for participation in the study

Exclusion Criteria:

* Cases with radiculopathy ipsilateral to the affected shoulder
* Cases with active inflammatory arthropathy of the affected shoulder
* Cases with previous shoulder surgery
* Cases with a history of humeral head, scapula, and clavicle fractures
* Cases with neurological deficit affecting the upper extremity
* Cases with uncontrolled diabetes mellitus and uncontrolled hypertension, uncompensated congestive heart failure, chronic renal failure, chronic liver disease, tumor and/or vascular disease, inflammatory and/or infectious diseases, currently active psychiatric disease
* Cases with a history of subacromial bursa injection, calcific lavage or shoulder joint injection in the last 3 months
* Cases with a history of allergic reaction to the substance to be applied as local anesthetic
* Pregnancy or lactation
* Anticoagulant or antiagregant (antiplatelet) medication use that may interfere with the injection procedure.

Primary outcomes:
measure: Change of Range of Motion
timeFrame: Baseline, 1 month
measure: Clinical improvement measured by change in Numeric Rating Scale
timeFrame: Baseline, 1 hour, 1 month
measure: Clinical improvement measured by change in Constant Shoulder Score
timeFrame: Baseline, 1 month
measure: Clinical improvement measured by change in Quick Dash Score
timeFrame: Baseline, 1 month
measure: Clinical improvement measured by change in Shoulder Disability Questionnaire
timeFrame: Baseline, 1 month
measure: Change in Gartner Score of the Shoulder Calcifications on Direct Radiography
timeFrame: Baseline, 1 month
measure: Change in ultrasound scoring system presented by Chiou
timeFrame: Baseline, 1 month
measure: Change in ultrasound classification system of calcific deposits presented by Farin
timeFrame: Baseline, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: NURI TUGBAY YILDIRAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: DENIZ PALAMAR
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: BILGE CAKIR
role: STUDY_CHAIR
References:
citation: Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
citation: Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
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citation: Chiou HJ, Chou YH, Wu JJ, Hsu CC, Huang DY, Chang CY. Evaluation of calcific tendonitis of the rotator cuff: role of color Doppler ultrasonography. J Ultrasound Med. 2002 Mar;21(3):289-95; quiz 296-7. doi: 10.7863/jum.2002.21.3.289.
citation: Farin PU, Jaroma H. Sonographic findings of rotator cuff calcifications. J Ultrasound Med. 1995 Jan;14(1):7-14. doi: 10.7863/jum.1995.14.1.7.
citation: Gartner J, Heyer A. [Calcific tendinitis of the shoulder]. Orthopade. 1995 Jun;24(3):284-302. German.
citation: Zhang T, Duan Y, Chen J, Chen X. Efficacy of ultrasound-guided percutaneous lavage for rotator cuff calcific tendinopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(21):e15552. doi: 10.1097/MD.0000000000015552.
citation: Lee S.H. (2020) Calcific Tendinitis Intervention. In: Peng P., Finlayson R., Lee S., Bhatia A. (eds) Ultrasound for Interventional Pain Management. Springer, Cham. https://doi.org/10.1007/978-3-030-18371-4_26