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

NCT03454321 | Completed

• 1 other identifier: RC17_0496
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinopathy

Keywords

Rotator cuff tendinopathy; ultrasound; subacromial bursitis; steroid injection

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• Reduction in shoulder pain 6 weeks after the subacromial steroid injection.

  6 weeks after the intervention

• Reduction in OSS score (Oxford Shoulder Score) 6 weeks and 3 months after the injection

  data from Day 0, Week 6 and Month 3

• Presence of other ultrasound lesions associated with a good response to steroid injection

  data from Day 0, Week 6 and Month 3

• Presence of radiographic abnormalities associated with a good response.

  data from Day 0, Week 6 and Month 3

• Steroid injection safety

  data from Day 0, Week 6 and Month 3

Interventions

Infiltration OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Major patients with manifestations of rotator cuff tendinopathy referred to our rheumatology department to receive an ultrasound-guided subacromial injection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, 44093, France

Location

Study Officials

• Christelle Darrieutort-Laffite

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 5, 2018
• Study Start: March 15, 2018
• Primary Completion: March 31, 2021
• Study Completion: September 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

FR (1)