An interventional study of tight control management and standard follow-up in Rotator Cuff Tendinopathy, sponsored by Nantes University Hospital. Recruiting at 8 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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).
Shoulder pain is a frequent reason for consultation, with a lifetime prevalence of 67%. Every year, around 1% of adults over 45 consult primary care because of shoulder pain. Of these, rotator cuff disorders account for around 70%. Pain associated with limited function has an impact on activities of daily living, and on professional activities, since the peak prevalence is between the ages of 45 and 64. They also represent a very costly problem, given the repeated absences from work they entail. Musculoskeletal disorders recognized as occupational illnesses are on the rise, with over 42,000 cases reported in France in 2012, 32% of them involving the shoulder. In 2006, the disease was estimated to have caused the loss of 7 million working days. A Swedish study also showed that the cost associated with painful shoulders was mainly represented by sick leave (84%).
Management of rotator cuff disorders initially involves symptomatic drug therapy (painkillers and non-steroidal anti-inflammatories), combined with rest and rehabilitation. Then, in case of insufficient improvement, subacromial steroid injection is often proposed. Despite the frequency of the condition, there are no established recommendations for the management of these patients. However, a recent study showed that the combination of posture advice and subacromial steroid injection was a more cost-effective strategy than either physiotherapy alone or infiltration alone. When we look at patients' outcome, chronic pain and impaired function are frequently seen, since 30-50% of patients still have symptoms after 1-2 years. It is therefore important to optimize the medical management of these patients, especially as at the stage of tendinopathy without rupture because surgical management is not always able to provide clinically significant benefits in terms of pain, function or quality of life.
In some chronic diseases, such as rheumatoid arthritis, it has been shown that early and tight control leads to better clinical results, as treatments are regularly and closely adapted to predefined objectives (remission or low disease activity). A significant improvement was also observed in diabetic patients under tight control leading to reduction in the risk of progression of retinal and neurological complications and significantly decreased risk of cardiovascular events.
The GREAT protocol is a prospective, randomized, multicenter study comparing two groups of patients:
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with new-onset shoulder pain related to rotator cuff tendinopathy
Exclusion Criteria:
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.
Other: tight control management
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.
Other: standard follow-up
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.
Patients are monitored according to standard practice
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Time frame: 6 months
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Time frame: 3 months and 12 months
pain at motion
Visual Analogic Scale / 100 mm
Time frame: 3 Months, 6 months, 12 months
Pain Self-Efficacy Questionnaire
10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain.
Time frame: 3 Months, 6 months, 12 months
Insomnia Severity Index
7 item auto-questionnaire
Time frame: 3 Months, 6 months, 12 months
number of shoulder surgeries
patients requiring shoulder surgery to manage their shoulder pain and/or disability
Time frame: 12 months
medico-economic study
Incremental cost-utility ratio (cost per QALY, Quality- Adjusted Life-Years)
Time frame: 12 months
Plan to share: Undecided
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Nantes University Hospital