Rotator Cuff TendinopathyIS'ECHONCT03454321
IS'ECHO : Impact of Bursitis on the Efficacy of Subacromial Steroid Injection in Rotator Cuff Tendinopathy
An observational study of Rotator Cuff Tendinopathy, run by Nantes University Hospital at 1 site in France.
Trial summary
Shoulder pain is a common reason for medical consultation affecting 6.7 % of the adults from 50 to 70 years old and until 21 % of the adults over 70. Among these painful shoulders, rotator cuff tendinopathy represents 44 to 65% of these consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Infiltration
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2018to 1 Sep 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will receive a subacromial ultrasound-guided injection for shoulder pain related to a rotator cuff tendinopathy
Who may be able to join
- Major patients with manifestations of rotator cuff tendinopathy referred to our rheumatology department to receive an ultrasound-guided subacromial injection.
Who cannot join
- Patients refusing to participate
- Allergic to local anesthetics
- Shoulder involvement of an inflammatory rheumatic disease
- History of shoulder surgery
- Shoulder instability
- Glenohumeral osteoarthritis
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?
Shoulder pain is a common reason for medical consultation affecting 6.7 % of the adults from 50 to 70 years old and until 21 % of the adults over 70. Among these painful shoulders, rotator cuff tendinopathy represents 44 to 65% of these consultations. To treat this condition, patients usually receive analgesics and physical therapy. When these treatments are not effective, a corticosteroid sub-acromial injection is proposed. However, according to the literature, there is only about 50% of good response to this subacromial injection in rotator cuff tendinopathy. It has been suggested that the injection could be more effective in the presence of an inflammation over the tendons called bursitis. However, no studies have clearly established this. The objective of the study is to determine if the presence of a bursitis could be a factor of good response to corticosteroid injection. The results could allow us to determine which patients have the best profile to respond to subacromial injection. The investigators hope that these data would improve the treatment of this frequent disease.
Read the 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).
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Infiltration
- Keywords
- Rotator cuff tendinopathy, ultrasound, subacromial bursitis, steroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfiltrationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
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
Measured: 3 months
Secondary outcomes (5)
Reduction in shoulder pain 6 weeks after the subacromial steroid injection.
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.
Measured: 6 weeks after the intervention
Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection
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).
Measured: data from Day 0, Week 6 and Month 3
Presence of other ultrasound lesions associated with a good response to steroid injection
The ultrasound lesions collected just before the injection will be :
- Bursitis: the bursitis is defined by a thickening of more than 2 mm of the subacromial bursae.
- Tendinous lesions (supra-spinatus, infra-spinatus or sub-scapularis): tendon thickening, hypoechoic density, presence of microcalcification, partial or complete tear
- Effusion of long head of biceps tendon sheath
- Acromio-clavicular joint lesions = synovitis, presence of Doppler flow, osteophytes
Measured: data from Day 0, Week 6 and Month 3
Presence of radiographic abnormalities associated with a good response.
X-ray data = Acromion Morphology according to Park's classification, Critical Shoulder Angle, acromioclavicular osteoarthritis
Measured: data from Day 0, Week 6 and Month 3
Steroid injection safety
Adverse events will be collected after the procedure and during follow-up.
Measured: data from Day 0, Week 6 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start15 Mar 2018
- Primary completion31 Mar 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Darrieutort-Laffite, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454321
- Sponsor's protocol ID
- RC17_0496
- Acronym
- IS'ECHO
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2018
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?
- ClinicalTrials.gov ID
- NCT03454321
- Acronym / sponsor ID
- IS'ECHO / RC17_0496
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Rotator cuff tendinopathy, ultrasound, subacromial bursitis, steroid injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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.
Shoulder pain is a common reason for medical consultation affecting 6.7 % of the adults from 50 to 70 years old and until 21 % of the adults over 70. Among these painful shoulders, rotator cuff tendinopathy represents 44 to 65% of these consultations. To treat this condition, patients usually receive analgesics and physical therapy. When these treatments are not effective, a corticosteroid sub-acromial injection is proposed. However, according to the literature, there is only about 50% of good response to this subacromial injection in rotator cuff tendinopathy. It has been suggested that the injection could be more effective in the presence of an inflammation over the tendons called bursitis. However, no studies have clearly established this. The objective of the study is to determine if the presence of a bursitis could be a factor of good response to corticosteroid injection. The results could allow us to determine which patients have the best profile to respond to subacromial injection. The investigators hope that these data would improve the treatment of this frequent disease.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will receive a subacromial ultrasound-guided injection for shoulder pain related to a rotator cuff tendinopathy
Key inclusion criteria (1 listed)
- Major patients with manifestations of rotator cuff tendinopathy referred to our rheumatology department to receive an ultrasound-guided subacromial injection.
Key exclusion criteria (13 listed)
- Patients refusing to participate
- Allergic to local anesthetics
- Shoulder involvement of an inflammatory rheumatic disease
- History of shoulder surgery
- Shoulder instability
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 |
|---|---|---|
| InfiltrationThe 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. | Other | – |
Primary outcome
Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
Time frame: 3 months
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
5 secondary outcomes
Reduction in shoulder pain 6 weeks after the subacromial steroid injection.
Time frame: 6 weeks after the intervention
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
Presence of other ultrasound lesions associated with a good response to steroid injection
Time frame: data from Day 0, Week 6 and Month 3
Presence of radiographic abnormalities associated with a good response.
Time frame: data from Day 0, Week 6 and Month 3
Steroid injection safety
Time frame: data from Day 0, Week 6 and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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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.
Christelle Darrieutort-Laffite principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tendinopathy, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 13 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: finished, as of the sponsor's last update on 13 Sep 2021. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in shoulder pain 3 months after the subacromial corticosteroid injection (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021.