Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Decrease in Pain as measured by the Visual analog scale from 1-10
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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)
Decreased Range of Motion in the shoulder measured in degrees
Time Frame: 8 months
Abduction, internal rotation, external rotation and circumduction of the shoulder
Secondary Outcomes
- Costs and health resource utilization as measured by administrative and billing data related to treatment(Up to 8-12 months post surgery)
- Complications and co existing conditions not detected prior to the procedure(Post ultrasound guided procedure through completion of study, up to one year)
- Generic physical and mental health as measured by EuroQol(Up to 8-12 months post surgery)
- The ultrasound appearance of the targeted calcification(Up to 8-12 months post surgery)
Investigators
Hema Choudur
Associate Professor, Department of Radiology
Hamilton Health Sciences Corporation