Tight management for shoulder pain from rotator cuff tendinopathy

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

This study is testing if more regular check-ins and support for people with early shoulder pain from rotator cuff tendinopathy can help them feel better faster compared to just one visit after three months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nantes University Hospital (other)
• Locations: 8 sites (Angers and 7 other locations)
• Trial ID: NCT06517680 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether close management of patients with early rotator cuff tendinopathy leads to better clinical outcomes compared to standard management. Participants will be randomly assigned to either a tight control group, receiving monthly consultations for three months, or a control group, which will have a single consultation after three months. The hypothesis is that more frequent follow-ups will result in quicker improvements and reduce the risk of chronic pain, along with a cost analysis of healthcare consumption and work absenteeism. The study addresses a common and costly issue affecting many adults, particularly those aged 45 to 64.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with new-onset shoulder pain related to rotator cuff tendinopathy lasting less than six months.

Not a fit: Patients with shoulder pain due to trauma, previous surgeries, or other specific shoulder disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to faster recovery and reduced chronicity for patients suffering from rotator cuff tendinopathy.

How similar studies have performed: Previous studies have indicated that structured management approaches can be more effective than standard care, suggesting potential success for this study's methodology.

Eligibility criteria

Inclusion Criteria :

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 Criteria:

* 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

Where this trial is running

Angers and 7 other locations

• CHU Angers — Angers, France (RECRUITING)
• CHU de Brest — Brest, France (RECRUITING)
• CHRU de Tours — Chambray-lès-Tours, France (RECRUITING)
• CH Cholet — Cholet, France (RECRUITING)
• CH Vendée — La Roche-sur-Yon, France (RECRUITING)
• CH du Mans — Le Mans, France (RECRUITING)
• CHU de Nantes — Nantes, France (RECRUITING)
• Chotard Emilie — Rennes, France (RECRUITING)

Study contacts

• Study coordinator: Christelle Darrieutort, PH

Conditions: Rotator Cuff Tendinopathy, Rotator cuff tendinopathy, tight control, injection