- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03454321
IS'ECHO : Impact of Bursitis on the Efficacy of Subacromial Steroid Injection in Rotator Cuff Tendinopathy (IS'ECHO)
Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?
Study Overview
Detailed Description
Patients referred to receive a subacromial ultrasound-guided injection for shoulder pain related to a rotator cuff tendinopathy will be enrolled in the study. After validation of the inclusion criteria, the participants will receive oral information about the protocol. Then, they will be examined and will undergo X-rays and an ultrasound of their shoulder. Pain shoulder and shoulder disability will be assessed before the injection with a visual analogic pain scale and the Oxford Shoulder Score questionnaire, respectively.
The subacromial injection will be performed under ultrasound guidance to accurately inject the subacromial bursae. After skin disinfection with povidone, the injection will be performed with a 21G needle. The bursae will be injected with 2 ml of lidocaine 2% and 1 ml of betamethasone.
After the procedure, the participants will all receive a standardized physiotherapy.
For primary outcome, the therapeutic response will be assessed 3 months after the procedure. Patients will be considered as having a good response if their level of pain decreases by over 30%.
The number of participants having a good clinical response will be compared between the patients presenting a bursitis and those without bursitis. The comparison will be made using a Chi-2 test.
Others parameters will be studied: reduction in pain 6 weeks after the injection, reduction in shoulder disability 6 weeks and 3 months after the injection. Other ultrasound lesions will be collected so as X-ray features to search other factors associated with the presence or absence of a good therapeutic response (details in secondary outcomes).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nantes, France, 44093
- CHU de Nantes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Major patients with manifestations of rotator cuff tendinopathy referred to our rheumatology department to receive an ultrasound-guided subacromial injection.
Exclusion Criteria:
- Patients refusing to participate
- Allergic to local anesthetics
- Shoulder involvement of an inflammatory rheumatic disease
- History of shoulder surgery
- Shoulder instability
- Glenohumeral osteoarthritis
- Frozen shoulder
- Extended rotator cuff tear
- Tendinous calcification > 0.5 cm
- Pregnant women
- Minors
- Majors under guardianship
- Patient inappropriate for entry into this study according to the judgment of the investigator
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
Time Frame: 3 months
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The primary outcome is the presence of a therapeutic response 3 months after the intervention. The level of pain will be assessed by a visual analogic pain scale of 0 (absence of pain) to 10 centimeters (maximal pain). Participants will be considered as good responders if their level of pain decreases more than 30 percent. Safety issue: No |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in shoulder pain 6 weeks after the subacromial steroid injection.
Time Frame: 6 weeks after the intervention
|
Presence of a therapeutic response 6 weeks after the intervention considering the reduction in pain between day 0 and Week 6 and assessed with the same scale as the primary outcome.
Participants will be considered as good responders if their level of pain decreases more than 30 percent.
|
6 weeks after the intervention
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Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection
Time Frame: data from Day 0, Week 6 and Month 3
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The OSS is a 12-item shoulder-specific questionnaire that was developed, with patients, for the assessment of shoulder pain and function.
Items refer to the past 4 weeks and each offers five ordinal response options.
These were scored from 1 to 5 (5 = most severe) and then conbined to produce a single score with a range from 12 (least difficulties) to 60 (most difficulties).
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data from Day 0, Week 6 and Month 3
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Presence of other ultrasound lesions associated with a good response to steroid injection
Time Frame: data from Day 0, Week 6 and Month 3
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The ultrasound lesions collected just before the injection will be :
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data from Day 0, Week 6 and Month 3
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Presence of radiographic abnormalities associated with a good response.
Time Frame: data from Day 0, Week 6 and Month 3
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X-ray data = Acromion Morphology according to Park's classification, Critical Shoulder Angle, acromioclavicular osteoarthritis
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data from Day 0, Week 6 and Month 3
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Steroid injection safety
Time Frame: data from Day 0, Week 6 and Month 3
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Adverse events will be collected after the procedure and during follow-up.
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data from Day 0, Week 6 and Month 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christelle Darrieutort-Laffite, CHU de Nantes
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- RC17_0496
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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