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

H

Hamilton Health Sciences (HHS)

Status

Unknown

Conditions

Rotator Cuff Calcific Tendonitis

Treatments

Other: Ultrasound guided Needle Fragmentation
Other: Ultrasound guided subacromial injection
Other: US guided needle fragmentation & Lavage

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 3 patient groups, including a placebo group

Ultrasound guided Needle Fragmentation
Active Comparator group
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.
Treatment:
Other: Ultrasound guided Needle Fragmentation
US guided needle fragmentation & Lavage
Active Comparator group
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.
Treatment:
Other: US guided needle fragmentation & Lavage
Ultrasound guided subacromial injection
Placebo Comparator group
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.
Treatment:
Other: Ultrasound guided subacromial injection

Trial contacts and locations

1

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Central trial contact

Hang Yu, BHSc.; Michelle L Kuang, BSc.

Data sourced from clinicaltrials.gov

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