Back to resultsUltrasound 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
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
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.
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
NCT ID
NCT02776345
First Posted
April 15, 2016
Last Updated
September 23, 2020
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Postgraduate Institute of Medical Education and Research
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:
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Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)
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