Tight Control for Rotator Cuff Tendinopathy (GREAT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tendinopathy
• Intervention / Treatment: Other: tight control management; Other: standard follow-up

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle Darrieutort, PH; Phone Number: 02 40 08 48 25; Email: christelle.darrieutort@chu-nantes.fr

Study Locations

• France
  • Angers, France, 49033
    • Recruiting
    • CHU Angers
    • Contact: Emmanuel Hoppe, PH; Phone Number: +33241353834; Email: emhoppe@chu-angers.fr
  • Brest, France, 29200
    • Recruiting
    • CHU de Brest
    • Contact: Anne Roudaut, PH; Phone Number: +33298347267; Email: dr.anne.roudaut@wanadoo.fr
  • Chambray-lès-Tours, France, 37170
    • Recruiting
    • Chru De Tours
    • Contact: Guillermo Carvajal Alegria, PH; Phone Number: +33218370589; Email: guillermo.carvajal@univ-tours.fr
  • Cholet, France, 49325
    • Recruiting
    • CH Cholet
    • Contact: Benoît Metayer, PH; Phone Number: +33241496430; Email: benoit.metayer@ch-cholet.fr
  • La Roche-sur-Yon, France, 85925
    • Recruiting
    • CH Vendée
    • Contact: Céline COZIC, PH; Phone Number: +33251446197; Email: celine.cozic@chd-vendee.fr
  • Le Mans, France, 72037
    • Recruiting
    • CH du Mans
    • Contact: Guillaume Direz, PH; Phone Number: +33244710730; Email: gdirez@ch-lemans.fr
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Christelle Darrieurtort, PH; Phone Number: 02 40 08 48 25; Email: christelle.darrieutort@chu-nantes.fr
  • Rennes, France, 35203
    • Recruiting
    • Chotard Emilie
    • Contact: Emilie CHotard, PH; Phone Number: +33299267140; Email: emilie.chotard@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: standard follow-up; Patients are monitored according to standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)	3 months and 12 months
pain at motion	Visual Analogic Scale / 100 mm	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.	3 Months, 6 months, 12 months
Insomnia Severity Index	7 item auto-questionnaire	3 Months, 6 months, 12 months
number of shoulder surgeries	patients requiring shoulder surgery to manage their shoulder pain and/or disability	12 months
medico-economic study	Incremental cost-utility ratio (cost per QALY, Quality- Adjusted Life-Years)	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): November 25, 2027
• Study Completion (Estimated): November 25, 2027

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Rotator cuff tendinopathy, tight control, injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: RC23_0421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No