Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)

Rotator Cuff Calcific Tendonitis Clinical Trial

— SUCTION  

Official title:

Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02776345
• Other study ID #: 1447
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: April 2022

Study information

• Verified date: September 2020
• Source: Hamilton Health Sciences Corporation
• Contact: Hang Yu, BHSc.
• Phone: 6478659385
• Email: henry.yu[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether minimally invasive treatments like ultrasound guided needle fragmentation with and without lavage is associated with better clinical outcomes compared to the subacromial bursal corticosteroid injection treatment only.

Description:

The objectives of this study are to compare the clinical outcomes of the three treatment arms: ultrasound guided needle fragmentation with lavage, ultrasound guided needle fragmentation without lavage, and subacromial bursal corticosteroid injection treatment. The study design is a randomized control trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Adult men or women ages 18 to 60 years

2. Shoulder pain ( including impingement pain) and reduced range of shoulder movement for greater than 6 months with no relief from non-operative means (physiotherapy, nonsteroidal anti-inflammatory medication, rest).

3. Documentation of failed physiotherapy and conservative management.

4. Calcific tendonitis as diagnosed on ultrasound.

5. Informed consent from participant.

6. Ability to speak, understand and read in the language of the clinical site.

Exclusion Criteria:

1. Previous inclusion in a study involving calcific tendonitis of the rotator cuff

2. Evidence of a calcification in any of the rotator cuff tendons except the supraspinatus tendon.

3. Presence of a tear of the rotator cuff.

4. The supraspinatus tendon calcification is more than 1.5 cm is its largest dimension.

5. Concomitant clinical or MRI diagnosis of frozen shoulder.

6. Previous rotator cuff or shoulder surgery.

7. Those on blood thinners.

8. Those with allergies to medication used.

9. Those with a skin infection at the site of needle entry.

10. Immunosuppressive medication use.

11. Chronic pain syndromes.

12. Significant medical co-morbidities (requiring daily assistance).

13. Ongoing litigation or compensation claims secondary to shoulder problems.

14. Age below 18 years and above 60 years.

15. Any other reasons given to exclude the patient.

Related Conditions & MeSH terms

• Rotator Cuff Calcific Tendonitis
• Tendinopathy

Intervention

Other:
• Ultrasound guided Needle Fragmentation
Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudocapsule. The needle tip will be retracted into the subacromial bursa and 3 ml of 0.5% sensorcaine and 1 ml of steroid ( Depomedrol- 40mg/ml) will be injected into the bursa. The needle will then be removed.
• US guided needle fragmentation & Lavage
Using local anesthetic and strict aseptic precautions, the tip of the 18-20 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 2ml. of local anesthetic ( 1% xylocaine) will be injected into the bursa. The needle tip will be advanced into the supraspinatus tendon and ½ ml or less of 0.5% Sensorcaine will be injected into the pseudo capsule around the calcification. Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudo capsule. During this procedure, or after the fragmentation, using a syringe of saline or local anesthetic( 1% xylocaine) and with pumping action of the syringe the calcification with be sucked into the syringe.
• Ultrasound guided subacromial injection
Using local anesthetic and strict aseptic precautions, the tip of the 22 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 4 ml. of local anesthetic ( 0.5% xylocaine) and 1 ml of steroid( Depomedrol 40 mg/ml) will be injected into the bursa. The needle will then be removed. Post procedure US images in the short and long axis planes will be obtained and documented. The patient's post procedure pain on a scale of 10 and their range of shoulder movement (abduction) will be assessed and documented.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

Canada, 

References & Publications (18)

Aina R, Cardinal E, Bureau NJ, Aubin B, Brassard P. Calcific shoulder tendinitis: treatment with modified US-guided fine-needle technique. Radiology. 2001 Nov;221(2):455-61. — View Citation

Chiou HJ, Chou YH, Wu JJ, Huang TF, Ma HL, Hsu CC, Chang CY. The role of high-resolution ultrasonography in management of calcific tendonitis of the rotator cuff. Ultrasound Med Biol. 2001 Jun;27(6):735-43. — View Citation

Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull. 1968 Oct;70(4):213-20. — View Citation

De Zordo T, Ahmad N, Ødegaard F, Girtler MT, Jaschke W, Klauser AS, Chhem RK, Romagnoli C. US-guided therapy of calcific tendinopathy: clinical and radiological outcome assessment in shoulder and non-shoulder tendons. Ultraschall Med. 2011 Jan;32 Suppl 1:S117-23. doi: 10.1055/s-0029-1245333. Epub 2010 Apr 22. — View Citation

del Cura JL, Torre I, Zabala R, Legórburu A. Sonographically guided percutaneous needle lavage in calcific tendinitis of the shoulder: short- and long-term results. AJR Am J Roentgenol. 2007 Sep;189(3):W128-34. — View Citation

Farin PU, Räsänen H, Jaroma H, Harju A. Rotator cuff calcifications: treatment with ultrasound-guided percutaneous needle aspiration and lavage. Skeletal Radiol. 1996 Aug;25(6):551-4. — View Citation

Fusaro I, Orsini S, Diani S, Saffioti G, Zaccarelli L, Galletti S. Functional results in calcific tendinitis of the shoulder treated with rehabilitation after ultrasonic-guided approach. Musculoskelet Surg. 2011 Jul;95 Suppl 1:S31-6. doi: 10.1007/s12306-011-0119-6. — View Citation

Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924-6. doi: 10.1136/bmj.39489.470347.AD. — View Citation

Kachewar SG, Kulkarni DS. Calcific tendinitis of the rotator cuff: a review. J Clin Diagn Res. 2013 Jul;7(7):1482-5. doi: 10.7860/JCDR/2013/4473.3180. Epub 2013 Jul 1. — View Citation

Ogon P, Suedkamp NP, Jaeger M, Izadpanah K, Koestler W, Maier D. Prognostic factors in nonoperative therapy for chronic symptomatic calcific tendinitis of the shoulder. Arthritis Rheum. 2009 Oct;60(10):2978-84. doi: 10.1002/art.24845. — View Citation

Oliva F, Via AG, Maffulli N. Physiopathology of intratendinous calcific deposition. BMC Med. 2012 Aug 23;10:95. doi: 10.1186/1741-7015-10-95. Review. — View Citation

Sconfienza LM, Bandirali M, Serafini G, Lacelli F, Aliprandi A, Di Leo G, Sardanelli F. Rotator cuff calcific tendinitis: does warm saline solution improve the short-term outcome of double-needle US-guided treatment? Radiology. 2012 Feb;262(2):560-6. doi: 10.1148/radiol.11111157. Epub 2011 Dec 5. — View Citation

Serafini G, Sconfienza LM, Lacelli F, Silvestri E, Aliprandi A, Sardanelli F. Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment--nonrandomized controlled trial. Radiology. 2009 Jul;252(1):1 — View Citation

Speed CA, Hazleman BL. Calcific tendinitis of the shoulder. N Engl J Med. 1999 May 20;340(20):1582-4. — View Citation

Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3. — View Citation

Vignesh KN, McDowall A, Simunovic N, Bhandari M, Choudur HN. Efficacy of ultrasound-guided percutaneous needle treatment of calcific tendinitis. AJR Am J Roentgenol. 2015 Jan;204(1):148-52. doi: 10.2214/AJR.13.11935. Review. — View Citation

Yoo JC, Koh KH, Park WH, Park JC, Kim SM, Yoon YC. The outcome of ultrasound-guided needle decompression and steroid injection in calcific tendinitis. J Shoulder Elbow Surg. 2010 Jun;19(4):596-600. doi: 10.1016/j.jse.2009.09.002. Epub 2009 Dec 2. — View Citation

Zhu J, Jiang Y, Hu Y, Xing C, Hu B. Evaluating the long-term effect of ultrasound-guided needle puncture without aspiration on calcifying supraspinatus tendinitis. Adv Ther. 2008 Nov;25(11):1229-34. doi: 10.1007/s12325-008-0115-x. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Pain as measured by the Visual analog scale from 1-10	Pain in the original symptomatic area of the rotator cuff will be reassessed using the visual analog scale from 1-10 (1 being the lowest pain and 10 being the highest)	8 months
Primary	Decreased Range of Motion in the shoulder measured in degrees	Abduction, internal rotation, external rotation and circumduction of the shoulder	8 months
Secondary	Complications and co existing conditions not detected prior to the procedure	Infection, procedure induced tendon tears, reduced range of motion ( from other causes such as frozen shoulder), and other adverse events	Post ultrasound guided procedure through completion of study, up to one year
Secondary	Costs and health resource utilization as measured by administrative and billing data related to treatment	Treatment-related costs to the healthcare system and/or patient through billing codes and data	Up to 8-12 months post surgery
Secondary	Generic physical and mental health as measured by EuroQol		Up to 8-12 months post surgery
Secondary	The ultrasound appearance of the targeted calcification		Up to 8-12 months post surgery