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

Primary Purpose

Rotator Cuff Calcific Tendonitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound guided Needle Fragmentation
US guided needle fragmentation & Lavage
Ultrasound guided subacromial injection
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Calcific Tendonitis focused on measuring calcific tendonitis, rotator cuff calcific tendonitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ultrasound guided Needle Fragmentation

US guided needle fragmentation & Lavage

Ultrasound guided subacromial injection

Arm Description

Ultrasound guided Needle Fragmentation (Intervention): 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.

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.

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.

Outcomes

Primary Outcome Measures

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)
Decreased Range of Motion in the shoulder measured in degrees
Abduction, internal rotation, external rotation and circumduction of the shoulder

Secondary Outcome Measures

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
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
Generic physical and mental health as measured by EuroQol
The ultrasound appearance of the targeted calcification

Full Information

First Posted
April 15, 2016
Last Updated
September 23, 2020
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02776345
Brief Title
Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)
Acronym
SUCTION
Official Title
Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Calcific Tendonitis
Keywords
calcific tendonitis, rotator cuff calcific tendonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided Needle Fragmentation
Arm Type
Active Comparator
Arm Description
Ultrasound guided Needle Fragmentation (Intervention): 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.
Arm Title
US guided needle fragmentation & Lavage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound guided subacromial injection
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Needle Fragmentation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
US guided needle fragmentation & Lavage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrasound guided subacromial injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in Pain as measured by the Visual analog scale from 1-10
Description
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)
Time Frame
8 months
Title
Decreased Range of Motion in the shoulder measured in degrees
Description
Abduction, internal rotation, external rotation and circumduction of the shoulder
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Complications and co existing conditions not detected prior to the procedure
Description
Infection, procedure induced tendon tears, reduced range of motion ( from other causes such as frozen shoulder), and other adverse events
Time Frame
Post ultrasound guided procedure through completion of study, up to one year
Title
Costs and health resource utilization as measured by administrative and billing data related to treatment
Description
Treatment-related costs to the healthcare system and/or patient through billing codes and data
Time Frame
Up to 8-12 months post surgery
Title
Generic physical and mental health as measured by EuroQol
Time Frame
Up to 8-12 months post surgery
Title
The ultrasound appearance of the targeted calcification
Time Frame
Up to 8-12 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult men or women ages 18 to 60 years 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). Documentation of failed physiotherapy and conservative management. Calcific tendonitis as diagnosed on ultrasound. Informed consent from participant. Ability to speak, understand and read in the language of the clinical site. Exclusion Criteria: Previous inclusion in a study involving calcific tendonitis of the rotator cuff Evidence of a calcification in any of the rotator cuff tendons except the supraspinatus tendon. Presence of a tear of the rotator cuff. The supraspinatus tendon calcification is more than 1.5 cm is its largest dimension. Concomitant clinical or MRI diagnosis of frozen shoulder. Previous rotator cuff or shoulder surgery. Those on blood thinners. Those with allergies to medication used. Those with a skin infection at the site of needle entry. Immunosuppressive medication use. Chronic pain syndromes. Significant medical co-morbidities (requiring daily assistance). Ongoing litigation or compensation claims secondary to shoulder problems. Age below 18 years and above 60 years. Any other reasons given to exclude the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Yu, BHSc.
Phone
6478659385
Email
henry.yu@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle L Kuang, BSc.
Phone
2899256990
Email
michelle.kuang@medportal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hema N Choudur, MBBS
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9L2X2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hema Choudur, MBBS,FRCPC
Phone
905-527-4322
Ext
46521
Email
choudur@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Hema N Choudur, MBBS,FRCPC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21479869
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.
Results Reference
background
PubMed Identifier
23998102
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.
Results Reference
background
PubMed Identifier
17715078
Citation
del Cura JL, Torre I, Zabala R, Legorburu 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. doi: 10.2214/AJR.07.2254.
Results Reference
background
PubMed Identifier
19959377
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.
Results Reference
background
PubMed Identifier
11687690
Citation
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. doi: 10.1148/radiol.2212000830.
Results Reference
background
PubMed Identifier
22143923
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.
Results Reference
background
PubMed Identifier
18436948
Citation
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann 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.
Results Reference
background
PubMed Identifier
19673146
Citation
Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull. 1968 Oct;70(4):213-20. doi: 10.1037/h0026256. No abstract available.
Results Reference
background
PubMed Identifier
15883903
Citation
Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
Results Reference
background
PubMed Identifier
18998062
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.
Results Reference
background
PubMed Identifier
11516532
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. doi: 10.1016/s0301-5629(01)00353-2.
Results Reference
background
PubMed Identifier
20414859
Citation
De Zordo T, Ahmad N, Odegaard 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.
Results Reference
background
PubMed Identifier
8865489
Citation
Farin PU, Rasanen 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. doi: 10.1007/s002560050133.
Results Reference
background
PubMed Identifier
22917025
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.
Results Reference
background
PubMed Identifier
19790063
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.
Results Reference
background
PubMed Identifier
25539250
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.
Results Reference
background
PubMed Identifier
10332023
Citation
Speed CA, Hazleman BL. Calcific tendinitis of the shoulder. N Engl J Med. 1999 May 20;340(20):1582-4. doi: 10.1056/NEJM199905203402011. No abstract available.
Results Reference
result
PubMed Identifier
19561254
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):157-64. doi: 10.1148/radiol.2521081816. Erratum In: Radiology. 2010 Feb;254(2):636.
Results Reference
result

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

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