Rotator Cuff Calcific TendonitisSUCTIONNCT02776345
Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff (SUCTION)
A study testing Ultrasound guided Needle Fragmentation, US guided needle fragmentation & Lavage and Ultrasound guided subacromial injection in people with Rotator Cuff Calcific Tendonitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Calcific Tendonitis
- What is being tested?
- Ultrasound guided Needle Fragmentation, US guided needle fragmentation & Lavage and Ultrasound guided subacromial injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton General Hospital
Hamilton, Ontario, L9L2X2
Hema Choudur, MBBS,FRCPC, 905-527-4322 ext. 46521, choudur@hhsc.ca
Hema N Choudur, MBBS,FRCPC
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Calcific Tendonitis
- Being tested
- Ultrasound guided Needle Fragmentation, US guided needle fragmentation & Lavage, Ultrasound guided subacromial injection
- Keywords
- calcific tendonitis, rotator cuff calcific tendonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Needle FragmentationOther
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.
US guided needle fragmentation & LavageOther
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.
Ultrasound guided subacromial injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided Needle Fragmentation | Active comparator | 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. Receives: Other: Ultrasound guided Needle Fragmentation |
| US guided needle fragmentation & Lavage | Active comparator | 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. Receives: Other: US guided needle fragmentation & Lavage |
| Ultrasound guided subacromial injection | Placebo comparator | 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. Receives: Other: Ultrasound guided subacromial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Pain as measured by the Visual analog scale from 1-10
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)
Measured: 8 months
Decreased Range of Motion in the shoulder measured in degrees
Abduction, internal rotation, external rotation and circumduction of the shoulder
Measured: 8 months
Secondary outcomes (4)
Complications and co existing conditions not detected prior to the procedure
Infection, procedure induced tendon tears, reduced range of motion ( from other causes such as frozen shoulder), and other adverse events
Measured: Post ultrasound guided procedure through completion of study, up to one year
Costs and health resource utilization as measured by administrative and billing data related to treatment
Treatment-related costs to the healthcare system and/or patient through billing codes and data
Measured: Up to 8-12 months post surgery
Generic physical and mental health as measured by EuroQol
Measured: Up to 8-12 months post surgery
The ultrasound appearance of the targeted calcification
Measured: Up to 8-12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMar 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Calcific TendonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Responsible party
- Principal investigator, Hema Choudur, Hamilton Health Sciences Corporation
- Investigators
- Hema N Choudur, MBBS, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776345
- Sponsor's protocol ID
- 1447
- Acronym
- SUCTION
- Status last verified
- Sep 2020
- First submitted
- 15 Apr 2016
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21479869Kachewar 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.
PubMed 23998102del 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.
PubMed 17715078Yoo 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.
PubMed 19959377Aina 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.
PubMed 11687690Sconfienza 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.
PubMed 22143923Guyatt 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.
PubMed 18436948Cohen 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.
PubMed 19673146Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
PubMed 15883903Zhu 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.
PubMed 18998062Chiou 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.
PubMed 11516532De 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.
PubMed 20414859Farin 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.
PubMed 8865489Oliva F, Via AG, Maffulli N. Physiopathology of intratendinous calcific deposition. BMC Med. 2012 Aug 23;10:95. doi: 10.1186/1741-7015-10-95.
PubMed 22917025Ogon 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.
PubMed 19790063
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)
- ClinicalTrials.gov ID
- NCT02776345
- Acronym / sponsor ID
- SUCTION / 1447
- Conditions
- Rotator Cuff Calcific Tendonitis
- Keywords
- calcific tendonitis, rotator cuff calcific tendonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Study start
- Mar 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided Needle Fragmentation | Active comparator | Other: Ultrasound guided Needle FragmentationUltrasound 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. |
| US guided needle fragmentation & Lavage | Active comparator | Other: US guided needle fragmentation & LavageUsing 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. |
| Ultrasound guided subacromial injection | Placebo comparator | Other: Ultrasound guided subacromial injectionUsing 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided Needle FragmentationUsing 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. | Other | Ultrasound guided Needle Fragmentation |
| US guided needle fragmentation & LavageUsing 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. | Other | US guided needle fragmentation & Lavage |
| Ultrasound guided subacromial injectionUsing 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. | Other | Ultrasound guided subacromial injection |
Primary outcome
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)
Decreased Range of Motion in the shoulder measured in degrees
Time frame: 8 months
Abduction, internal rotation, external rotation and circumduction of the shoulder
4 secondary outcomes
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
Costs and health resource utilization as measured by administrative and billing data related to treatment
Time frame: 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
The ultrasound appearance of the targeted calcification
Time frame: Up to 8-12 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 21479869Fusaro 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.
- Background: PubMed 23998102Kachewar 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.
- Background: PubMed 17715078del 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.
- Background: PubMed 19959377Yoo 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.
- Background: PubMed 11687690Aina 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.
- Background: PubMed 22143923Sconfienza 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.
- Background: PubMed 18436948Guyatt 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.
- Background: PubMed 19673146Cohen 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.
- Background: PubMed 15883903Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
- Background: PubMed 18998062Zhu 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.
- Background: PubMed 11516532Chiou 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.
- Background: PubMed 20414859De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hema N Choudur, MBBS principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Needle Fragmentation, US guided needle fragmentation & Lavage and Ultrasound guided subacromial injection in people with Rotator Cuff Calcific Tendonitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hang Yu, BHSc. (6478659385, henry.yu@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Pain as measured by the Visual analog scale from 1-10 (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776345, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.