IS'ECHO : Impact of Bursitis on the Efficacy of Subacromial Steroid Injection in Rotator Cuff Tendinopathy

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03454321

Collaborator

(none)

100

Enrollment

Location

41.6

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tendinopathy	Other: Infiltration

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Is the Presence of Subacromial Bursitis Associated With a Good Response to Ultrasound-guided Steroid Injection in Rotator Cuff Tendinopathy?

Actual Study Start Date :

Mar 15, 2018

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Sep 1, 2021

Outcome Measures

Primary Outcome Measures

Reduction in shoulder pain 3 months after the subacromial corticosteroid injection [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

Secondary Outcome Measures

Reduction in shoulder pain 6 weeks after the subacromial steroid injection. [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.
Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection [data from Day 0, Week 6 and Month 3]
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).
Presence of other ultrasound lesions associated with a good response to steroid injection [data from Day 0, Week 6 and Month 3]
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
Presence of radiographic abnormalities associated with a good response. [data from Day 0, Week 6 and Month 3]
X-ray data = Acromion Morphology according to Park's classification, Critical Shoulder Angle, acromioclavicular osteoarthritis
Steroid injection safety [data from Day 0, Week 6 and Month 3]
Adverse events will be collected after the procedure and during follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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