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

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.

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.

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.