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
Verified date | January 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University- Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
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
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 |
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