- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776345
Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION) (SUCTION)
Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hang Yu, BHSc.
- Phone Number: 6478659385
- Email: henry.yu@medportal.ca
Study Contact Backup
- Name: Michelle L Kuang, BSc.
- Phone Number: 2899256990
- Email: michelle.kuang@medportal.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L9L2X2
- Hamilton General Hospital
-
Contact:
- Hema Choudur, MBBS,FRCPC
- Phone Number: 46521 905-527-4322
- Email: choudur@hhsc.ca
-
Principal Investigator:
- Hema N Choudur, MBBS,FRCPC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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. |
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.
|
Active Comparator: 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.
|
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.
|
Placebo Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
8 months
|
Decreased Range of Motion in the shoulder measured in degrees
Time Frame: 8 months
|
Abduction, internal rotation, external rotation and circumduction of the shoulder
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications and co existing conditions not detected prior to the procedure
Time Frame: 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
|
Post ultrasound guided procedure through completion of study, up to one year
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Costs and health resource utilization as measured by administrative and billing data related to treatment
Time Frame: Up to 8-12 months post surgery
|
Treatment-related costs to the healthcare system and/or patient through billing codes and data
|
Up to 8-12 months post surgery
|
Generic physical and mental health as measured by EuroQol
Time Frame: Up to 8-12 months post surgery
|
Up to 8-12 months post surgery
|
|
The ultrasound appearance of the targeted calcification
Time Frame: Up to 8-12 months post surgery
|
Up to 8-12 months post surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hema N Choudur, MBBS, Hamilton Health Sciences Corporation
Publications and helpful links
General Publications
- Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull. 1968 Oct;70(4):213-20. doi: 10.1037/h0026256. No abstract available.
- Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924-6. doi: 10.1136/bmj.39489.470347.AD.
- Fusaro I, Orsini S, Diani S, Saffioti G, Zaccarelli L, Galletti S. Functional results in calcific tendinitis of the shoulder treated with rehabilitation after ultrasonic-guided approach. Musculoskelet Surg. 2011 Jul;95 Suppl 1:S31-6. doi: 10.1007/s12306-011-0119-6.
- Kachewar SG, Kulkarni DS. Calcific tendinitis of the rotator cuff: a review. J Clin Diagn Res. 2013 Jul;7(7):1482-5. doi: 10.7860/JCDR/2013/4473.3180. Epub 2013 Jul 1.
- del Cura JL, Torre I, Zabala R, Legorburu A. Sonographically guided percutaneous needle lavage in calcific tendinitis of the shoulder: short- and long-term results. AJR Am J Roentgenol. 2007 Sep;189(3):W128-34. doi: 10.2214/AJR.07.2254.
- Yoo JC, Koh KH, Park WH, Park JC, Kim SM, Yoon YC. The outcome of ultrasound-guided needle decompression and steroid injection in calcific tendinitis. J Shoulder Elbow Surg. 2010 Jun;19(4):596-600. doi: 10.1016/j.jse.2009.09.002. Epub 2009 Dec 2.
- Aina R, Cardinal E, Bureau NJ, Aubin B, Brassard P. Calcific shoulder tendinitis: treatment with modified US-guided fine-needle technique. Radiology. 2001 Nov;221(2):455-61. doi: 10.1148/radiol.2212000830.
- Sconfienza LM, Bandirali M, Serafini G, Lacelli F, Aliprandi A, Di Leo G, Sardanelli F. Rotator cuff calcific tendinitis: does warm saline solution improve the short-term outcome of double-needle US-guided treatment? Radiology. 2012 Feb;262(2):560-6. doi: 10.1148/radiol.11111157. Epub 2011 Dec 5.
- Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
- Zhu J, Jiang Y, Hu Y, Xing C, Hu B. Evaluating the long-term effect of ultrasound-guided needle puncture without aspiration on calcifying supraspinatus tendinitis. Adv Ther. 2008 Nov;25(11):1229-34. doi: 10.1007/s12325-008-0115-x.
- Chiou HJ, Chou YH, Wu JJ, Huang TF, Ma HL, Hsu CC, Chang CY. The role of high-resolution ultrasonography in management of calcific tendonitis of the rotator cuff. Ultrasound Med Biol. 2001 Jun;27(6):735-43. doi: 10.1016/s0301-5629(01)00353-2.
- De Zordo T, Ahmad N, Odegaard F, Girtler MT, Jaschke W, Klauser AS, Chhem RK, Romagnoli C. US-guided therapy of calcific tendinopathy: clinical and radiological outcome assessment in shoulder and non-shoulder tendons. Ultraschall Med. 2011 Jan;32 Suppl 1:S117-23. doi: 10.1055/s-0029-1245333. Epub 2010 Apr 22.
- Farin PU, Rasanen H, Jaroma H, Harju A. Rotator cuff calcifications: treatment with ultrasound-guided percutaneous needle aspiration and lavage. Skeletal Radiol. 1996 Aug;25(6):551-4. doi: 10.1007/s002560050133.
- Oliva F, Via AG, Maffulli N. Physiopathology of intratendinous calcific deposition. BMC Med. 2012 Aug 23;10:95. doi: 10.1186/1741-7015-10-95.
- Ogon P, Suedkamp NP, Jaeger M, Izadpanah K, Koestler W, Maier D. Prognostic factors in nonoperative therapy for chronic symptomatic calcific tendinitis of the shoulder. Arthritis Rheum. 2009 Oct;60(10):2978-84. doi: 10.1002/art.24845.
- Vignesh KN, McDowall A, Simunovic N, Bhandari M, Choudur HN. Efficacy of ultrasound-guided percutaneous needle treatment of calcific tendinitis. AJR Am J Roentgenol. 2015 Jan;204(1):148-52. doi: 10.2214/AJR.13.11935.
- Speed CA, Hazleman BL. Calcific tendinitis of the shoulder. N Engl J Med. 1999 May 20;340(20):1582-4. doi: 10.1056/NEJM199905203402011. No abstract available.
- Serafini G, Sconfienza LM, Lacelli F, Silvestri E, Aliprandi A, Sardanelli F. Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment--nonrandomized controlled trial. Radiology. 2009 Jul;252(1):157-64. doi: 10.1148/radiol.2521081816. Erratum In: Radiology. 2010 Feb;254(2):636.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1447
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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