Tight Control for Rotator Cuff Tendinopathy

NCT ID: NCT06517680

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2027-11-25

Brief 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).

Detailed Description

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:

• In the experimental or "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 will be proposed in line with predefined objectives.
• In the 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.

Conditions

Rotator Cuff Tendinopathy

Keywords

Rotator cuff tendinopathy, tight control, injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tight control management

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

standard follow-up

Intervention Type: OTHER

Patients are monitored according to standard practice

Interventions

tight 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.

Intervention Type: OTHER

standard follow-up

Patients are monitored according to standard practice

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Angers

Angers, , France

Site Status: RECRUITING

CHU de Brest

Brest, , France

Site Status: RECRUITING

CHRU de Tours

Chambray-lès-Tours, , France

Site Status: RECRUITING

CH Cholet

Cholet, , France

Site Status: RECRUITING

CH Vendée

La Roche-sur-Yon, , France

Site Status: RECRUITING

CH du Mans

Le Mans, , France

Site Status: RECRUITING

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

Chotard Emilie

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christelle Darrieutort, PH

Role: CONTACT

Phone: 02 40 08 48 25

Email: christelle.darrieutort@chu-nantes.fr

Facility Contacts

Emmanuel Hoppe, PH

Role: primary

Anne Roudaut, PH

Role: primary

Guillermo Carvajal Alegria, PH

Role: primary

Benoît Metayer, PH

Role: primary

Céline COZIC, PH

Role: primary

Guillaume Direz, PH

Role: primary

Christelle Darrieurtort, PH

Role: primary

Emilie CHotard, PH

Role: primary

Other Identifiers

RC23_0421

Identifier Type: -

Identifier Source: org_study_id