Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis
NCT ID: NCT05272085
Last Updated: 2023-01-31
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2022-03-09
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ultrasound Guided Lavage Group
The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging.
Patients in this group will be treated with ultrasound-guided lavage.
Ultrasound Guided Lavage
After local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.
Ultrasound Guided Subacromial Bursa Injection Group
The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging.
Patients in this group will be treated with ultrasound-guided subacromial bursa injection with corticosteroid and lidocaine.
Ultrasound Guided Subacromial Bursa Injection
2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.
Interventions
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Ultrasound Guided Lavage
After local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.
Ultrasound Guided Subacromial Bursa Injection
2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Nuri Tugbay Yildiran
Principal Investigator
Principal Investigators
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NURI TUGBAY YILDIRAN
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
DENIZ PALAMAR
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa
BILGE CAKIR
Role: STUDY_CHAIR
Istanbul University - Cerrahpasa
Locations
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Istanbul University- Cerrahpaşa
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Sansone V, Consonni O, Maiorano E, Meroni R, Goddi A. Calcific tendinopathy of the rotator cuff: the correlation between pain and imaging features in symptomatic and asymptomatic female shoulders. Skeletal Radiol. 2016 Jan;45(1):49-55. doi: 10.1007/s00256-015-2240-3. Epub 2015 Aug 27.
Greis AC, Derrington SM, McAuliffe M. Evaluation and nonsurgical management of rotator cuff calcific tendinopathy. Orthop Clin North Am. 2015 Apr;46(2):293-302. doi: 10.1016/j.ocl.2014.11.011. Epub 2015 Jan 27.
de Witte PB, Selten JW, Navas A, Nagels J, Visser CP, Nelissen RG, Reijnierse M. Calcific tendinitis of the rotator cuff: a randomized controlled trial of ultrasound-guided needling and lavage versus subacromial corticosteroids. Am J Sports Med. 2013 Jul;41(7):1665-73. doi: 10.1177/0363546513487066. Epub 2013 May 21.
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.
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.
Gartner J, Heyer A. [Calcific tendinitis of the shoulder]. Orthopade. 1995 Jun;24(3):284-302. German.
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.
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
Other Identifiers
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IstanbulUC-NTugbayYildiran-01
Identifier Type: -
Identifier Source: org_study_id
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