Actively Recruiting
Efficacy of Tight Treatment in Rotator Cuff Tendinopathy Compared to Standard Management: A Randomized Controlled Trial
Led by Nantes University Hospital · Updated on 2026-01-15
156
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if closely monitoring patients early in rotator cuff tendinopathy leads to better clinical improvement compared to standard care. Rotator cuff disorders are common causes of shoulder pain, affecting daily activities and work, especially in adults aged 45 to 64. The study explores whether tight control can speed recovery, reduce chronic cases, and lower healthcare costs including sick leave and treatment expenses. The study compares two management approaches: a tight control group and a standard follow-up group. Patients in the tight control group will have monthly consultations for the first three months to assess shoulder pain and function, with treatment adjustments such as steroid injections, medications, or physiotherapy based on set goals. The control group will receive usual care with one follow-up visit three months after the initial consultation to review their progress. Participants will be evaluated using the Oxford Shoulder Score over 3, 6, and 12 months, pain assessments during motion, pain self-efficacy questionnaires, and insomnia severity indexes. Researchers will also track the number of shoulder surgeries and conduct a medico-economic analysis over 12 months. The total participation includes regular assessments and treatment monitoring to measure clinical outcomes and cost-effectiveness over time.
CONDITIONS
Brief Title
Tight Control for Rotator Cuff Tendinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with new-onset shoulder pain related to rotator cuff tendinopathy
- Age between 18 and 65 years
- Shoulder pain on activity for less than 6 months with VAS ≥4/10 and/or Oxford Shoulder Score ≥20
- Pain compatible with rotator cuff tendinopathy according to BESS guidelines
You will not qualify if you...
- 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 such as inflammatory arthritis, frozen shoulder, glenohumeral joint instability, or acromioclavicular arthropathy
- Tendon calcification greater than 0.5 cm
- Previous shoulder surgery
- Full-thickness tear of one tendon
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants are assigned to either tight control management with monthly visits and treatment adjustments or standard follow-up with a consultation at 3 months to assess their clinical course.
Monthly visits for up to 3 months for the tight control group; 1 visit at 3 months for the standard follow-up group
Duration - Up to 12 months
Participants are assessed for shoulder function and pain at 6 and 12 months after treatment to evaluate long-term outcomes.
Visits at 6 months and 12 months
Trial Site Locations
Total: 8 locations
1
CHU Angers
Angers, France, 49033
Actively Recruiting
2
CHU de Brest
Brest, France, 29200
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3
CHRU de Tours
Chambray-lès-Tours, France, 37170
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4
CH Cholet
Cholet, France, 49325
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5
CH Vendée
La Roche-sur-Yon, France, 85925
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6
CH du Mans
Le Mans, France, 72037
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7
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
8
Chotard Emilie
Rennes, France, 35203
Actively Recruiting
Research Team
C
Christelle Darrieutort, PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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