Efficacy of Tight Treatment in Rotator Cuff Tendinopathy Rotator Cuff Tendinopathy: a Randomized Controlled Trial Versus Standard Standard Management

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main objective of the study is to determine whether tight management of patients in early rotator cuff tendinopathy would lead to better clinical improvement than standard management. In a randomized study, we propose to compare two types of management, with a tight control group having one consultation per month for the first 3 months, in order to readapt or intensify management, whereas the control group will only be seen at 3 months after inclusion. We hypothesize that this close follow-up will lead to more rapid clinical improvement and reduce the transition to chronicity and the associated costs (inclusion of a medico-economic analysis taking into account, in particular, healthcare consumption and time off work).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ Patient with new-onset shoulder pain related to rotator cuff tendinopathy

• Age between 18 and 65

• Shoulder pain on activity for less than 6 months with VAS≥4/10 and/or OSS≥20

• Pain compatible with rotator cuff tendinopathy according to the rotator cuff tendinopathy according to the BESS (British Elbow and Shoulder Society) guidelines

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU de Brest
RECRUITING
Brest
CHRU de Tours
RECRUITING
Chambray-lès-tours
CH Cholet
RECRUITING
Cholet
CH Vendée
RECRUITING
La Roche-sur-yon
CH du Mans
RECRUITING
Le Mans
CHU de Nantes
RECRUITING
Nantes
Chotard Emilie
RECRUITING
Rennes
Contact Information
Primary
Christelle Darrieutort, PH
christelle.darrieutort@chu-nantes.fr
02 40 08 48 25
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2027-11-25
Participants
Target number of participants: 156
Treatments
Experimental: Tight control group
Patients will be seen every month for the first 3 months of follow-up During these consultations, shoulder pain and function will be assessed. Treatment adjustments (steroid injections, drugs and physiotherapy) will be proposed in line with predefined objectives.
Active_comparator: Control group
Patients will have the usual follow-up for this indication, i.e. a follow-up consultation 3 months after the 1st consultation with the rheumatologist to assess their clinical course.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov