Clinical trial NCT03454321: IS'ECHO : Impact of Bursitis on the Efficacy of Subacromial Steroid Injection in Rotator Cuff Tendinopathy
Official title: Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tendinopathy
Keywords: Rotator cuff tendinopathy
ultrasound
subacromial bursitis
steroid injection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will receive a subacromial ultrasound-guided injection for shoulder pain related to a rotator cuff tendinopathy

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in shoulder pain 3 months after the subacromial corticosteroid injection
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in shoulder pain 6 weeks after the subacromial steroid injection.
timeFrame: 6 weeks after the intervention
measure: Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection
timeFrame: data from Day 0, Week 6 and Month 3
measure: Presence of other ultrasound lesions associated with a good response to steroid injection
timeFrame: data from Day 0, Week 6 and Month 3
measure: Presence of radiographic abnormalities associated with a good response.
timeFrame: data from Day 0, Week 6 and Month 3
measure: Steroid injection safety
timeFrame: data from Day 0, Week 6 and Month 3
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Christelle Darrieutort-Laffite
role: PRINCIPAL_INVESTIGATOR
References: