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

Primary Purpose

Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Ultrasound Guided Lavage

Ultrasound Guided Subacromial Bursa Injection

About this trial

This is an interventional treatment trial for Calcific Tendinitis focused on measuring Calcific tendinitis, Shoulder pain, Ultrasound-guided, Lavage, Barbotage, subacromial bursa injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Istanbul University- Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ultrasound Guided Lavage Group

Ultrasound Guided Subacromial Bursa Injection Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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"

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.

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).

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

Change in Gartner Score of the Shoulder Calcifications on Direct Radiography

Radiological classification of calcifying tendinitis

Change in ultrasound scoring system presented by Chiou

This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05272085

First Posted

February 20, 2022

Last Updated

January 30, 2023

Sponsor

Istanbul University - Cerrahpasa (IUC)

1. Study Identification

Unique Protocol Identification Number

NCT05272085

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 9, 2022 (Actual)

Primary Completion Date

August 30, 2022 (Actual)

Study Completion Date

November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain

Keywords

Calcific tendinitis, Shoulder pain, Ultrasound-guided, Lavage, Barbotage, subacromial bursa injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound Guided Lavage Group

Arm Type

Active Comparator

Arm Description

Arm Title

Ultrasound Guided Subacromial Bursa Injection Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Lavage

Other Intervention Name(s)

Ultrasound Guided Barbotage

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Subacromial Bursa Injection

Intervention Description

2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.

Primary Outcome Measure Information:

Title

Change of Range of Motion

Description

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.

Time Frame

Baseline, 1 month

Title

Clinical improvement measured by change in Numeric Rating Scale

Description

Time Frame

Baseline, 1 hour, 1 month

Title

Clinical improvement measured by change in Constant Shoulder Score

Description

Time Frame

Baseline, 1 month

Title

Clinical improvement measured by change in Quick Dash Score

Description

Time Frame

Baseline, 1 month

Title

Clinical improvement measured by change in Shoulder Disability Questionnaire

Description

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

Time Frame

Baseline, 1 month

Title

Change in Gartner Score of the Shoulder Calcifications on Direct Radiography

Description

Radiological classification of calcifying tendinitis

Time Frame

Baseline, 1 month

Title

Change in ultrasound scoring system presented by Chiou

Description

This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.

Time Frame

Baseline, 1 month

Title

Change in ultrasound classification system of calcific deposits presented by Farin

Description

This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)

Time Frame

Baseline, 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

NURI TUGBAY YILDIRAN

Organizational Affiliation

Istanbul University - Cerrahpasa (IUC)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

DENIZ PALAMAR

Organizational Affiliation

Istanbul University - Cerrahpasa (IUC)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

BILGE CAKIR

Organizational Affiliation

Istanbul University - Cerrahpasa (IUC)

Official's Role

Study Chair

Facility Information:

Facility Name

Istanbul University- Cerrahpaşa

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25870115

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.

Results Reference

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PubMed Identifier

30774461

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.

Results Reference

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PubMed Identifier

26306389

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.

Results Reference

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PubMed Identifier

25771323

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.

Results Reference

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PubMed Identifier

23696211

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.

Results Reference

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PubMed Identifier

11883540

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.

Results Reference

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PubMed Identifier

7707483

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.

Results Reference

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PubMed Identifier

7617385

Citation

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

Results Reference

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PubMed Identifier

31124934

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.

Results Reference

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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

Results Reference

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

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