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Ultrasound guided Needle Fragmentation for Rotator Cuff Tendonitis (SUCTION Trial)

N/A
Waitlist Available
Led By Hema N Choudur, MBBS
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post ultrasound guided procedure through completion of study, up to one year
Awards & highlights

SUCTION Trial Summary

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

Eligible Conditions
  • Rotator Cuff Tendonitis

SUCTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post ultrasound guided procedure through completion of study, up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and post ultrasound guided procedure through completion of study, up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decrease in Pain as measured by the Visual analog scale from 1-10
Decreased Range of Motion in the shoulder measured in degrees
Secondary outcome measures
Complications and co existing conditions not detected prior to the procedure
Costs and health resource utilization as measured by administrative and billing data related to treatment
Generic physical and mental health as measured by EuroQol
+1 more

SUCTION Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Ultrasound guided Needle FragmentationActive Control1 Intervention
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.
Group II: US guided needle fragmentation & LavageActive Control1 Intervention
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.
Group III: Ultrasound guided subacromial injectionPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Postgraduate Institute of Medical Education and ResearchUNKNOWN
269 Previous Clinical Trials
95,972 Total Patients Enrolled
Post Graduate Institute of Medical Education and Research, ChandigarhOTHER
293 Previous Clinical Trials
112,503 Total Patients Enrolled
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,833 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The American Journal of GastroenterologyJournal
Evidence-based Medicine (EBM) in Practice: Agreement Between Observers Rating Esophageal Varices: How to Cope with Chance?
Sierra, Fernando, and Andrés Cárdenas. 2007. “Evidence-based Medicine (EBM) in Practice: Agreement Between Observers Rating Esophageal Varices: How to Cope with Chance?”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.2007.01225.x.
clinicaltrials.govStudy
Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)
Hema Choudur 2021. "Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02776345.
~39 spots leftby Apr 2025
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