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

Not Applicable

• Conditions: Rotator Cuff Calcific Tendonitis
• Interventions: Other: Ultrasound guided Needle Fragmentation; Other: Ultrasound guided subacromial injection; Other: US guided needle fragmentation & Lavage

• Registration Number: NCT02776345
• Lead Sponsor: Hamilton Health Sciences Corporation

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 Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25
• Study Start: 2021-03
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided Needle Fragmentation	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.
Ultrasound guided subacromial injection	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.
US guided needle fragmentation & Lavage	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.

Primary Outcome Measures

Name	Time	Method
Decrease in Pain as measured by the Visual analog scale from 1-10	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	8 months	Abduction, internal rotation, external rotation and circumduction of the shoulder

Secondary Outcome Measures

Name	Time	Method
Complications and co existing conditions not detected prior to the procedure	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
Costs and health resource utilization as measured by administrative and billing data related to treatment	Up to 8-12 months post surgery	Treatment-related costs to the healthcare system and/or patient through billing codes and data
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

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada