RecruitingNot ApplicableNCT06517680

Tight Control for Rotator Cuff Tendinopathy

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


Sponsor

Nantes University Hospital

Enrollment

156 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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

Exclusion Criteria9

  • Contraindication to steroid injections
  • Shoulder pain related to trauma (dislocation, fracture) or acute tendon rupture requiring short-term surgery
  • Steroid injection already performed on the shoulder studied for the current episode
  • Neurological pathology affecting the shoulder
  • Other shoulder disorders (inflammatory arthritis, frozen shoulder, glenohumeral joint instability, pain associated with acromioclavicular arthropathy)
  • Tendon calcification > 0.5 cm.
  • Previous shoulder surgery
  • Full-thickness tear of one tendon
  • Pregnant women

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Interventions

OTHERtight control management

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.

OTHERstandard follow-up

Patients are monitored according to standard practice


Locations(8)

CHU Angers

Angers, France

CHU de Brest

Brest, France

CHRU de Tours

Chambray-lès-Tours, France

CH Cholet

Cholet, France

CH Vendée

La Roche-sur-Yon, France

CH du Mans

Le Mans, France

CHU de Nantes

Nantes, France

Chotard Emilie

Rennes, France

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NCT06517680


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