Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis

Shoulder Pain Clinical Trial

Official title:

Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05272085
• Other study ID #: IstanbulUC-NTugbayYildiran-01
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calcific Tendinitis
• Shoulder Pain
• Tendinopathy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View 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. — View Citation

Gartner J, Heyer A. [Calcific tendinitis of the shoulder]. Orthopade. 1995 Jun;24(3):284-302. German. — View Citation

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. — View 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

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Range of Motion	The change in a participant's range of motion degree as measured by a goniometer (Passive Range of Motion and Active Range of Motion) from baseline to 1 month.	Baseline, 1 month
Primary	Clinical improvement measured by change in Numeric Rating Scale	A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. A patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "worst possible pain"	Baseline, 1 hour, 1 month
Primary	Clinical improvement measured by change in Constant Shoulder Score	The constant shoulder score is a validated scale, measuring the shoulder function. It is an objective measurement independent of the shoulder pain. It is a 100-points scale composed of a number of individual parameters. The minimum score is 0, the maximum score is 100 points. The higher the score, the higher the quality of the function.	Baseline, 1 month
Primary	Clinical improvement measured by change in Quick Dash Score	Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11 item Quick Dash questionnaire. 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).	Baseline, 1 month
Primary	Clinical improvement measured by change in Shoulder Disability Questionnaire	This score measures the disability of the shoulder in daily life, work, social life.0 points indicate maximum well-being, 100 points indicate maximum disability	Baseline, 1 month
Primary	Change in Gartner Score of the Shoulder Calcifications on Direct Radiography	Radiological classification of calcifying tendinitis	Baseline, 1 month
Primary	Change in ultrasound scoring system presented by Chiou	This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.	Baseline, 1 month
Primary	Change in ultrasound classification system of calcific deposits presented by Farin	This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)	Baseline, 1 month