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

September 23, 2020 updated by: Hema Choudur, Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9L2X2
        • Hamilton General Hospital
        • Contact:
          • Hema Choudur, MBBS,FRCPC
          • Phone Number: 46521 905-527-4322
          • Email: choudur@hhsc.ca
        • Principal Investigator:
          • Hema N Choudur, MBBS,FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound guided Needle Fragmentation

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.
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.
Active Comparator: 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.
Other: 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.
Placebo Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Pain as measured by the Visual analog scale from 1-10
Time Frame: 8 months
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
Decreased Range of Motion in the shoulder measured in degrees
Time Frame: 8 months
Abduction, internal rotation, external rotation and circumduction of the shoulder
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications and co existing conditions not detected prior to the procedure
Time Frame: Post ultrasound guided procedure through completion of study, up to one year
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
Costs and health resource utilization as measured by administrative and billing data related to treatment
Time Frame: Up to 8-12 months post surgery
Treatment-related costs to the healthcare system and/or patient through billing codes and data
Up to 8-12 months post surgery
Generic physical and mental health as measured by EuroQol
Time Frame: Up to 8-12 months post surgery
Up to 8-12 months post surgery
The ultrasound appearance of the targeted calcification
Time Frame: Up to 8-12 months post surgery
Up to 8-12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Hema N Choudur, MBBS, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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