Rotator Cuff TendinopathyGREATNCT06517680
Tight Control for Rotator Cuff Tendinopathy
A study testing standard follow-up in people with Rotator Cuff Tendinopathy, run by Nantes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- standard follow-up
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 8 sitesFrance
- Study dates
- 25 Nov 2024to 25 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Previous shoulder surgery
- Full-thickness tear of one tendon
- Pregnant women
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU Angers
Angers, 49033
Emmanuel Hoppe, PH, +33241353834, emhoppe@chu-angers.fr
- Recruiting
CHU de Brest
Brest, 29200
Anne Roudaut, PH, +33298347267, dr.anne.roudaut@wanadoo.fr
- Recruiting
CHRU de Tours
Chambray-lès-Tours, 37170
Guillermo Carvajal Alegria, PH, +33218370589, guillermo.carvajal@univ-tours.fr
- Recruiting
CH Cholet
Cholet, 49325
Benoît Metayer, PH, +33241496430, benoit.metayer@ch-cholet.fr
- Recruiting
CH Vendée
La Roche-sur-Yon, 85925
Céline COZIC, PH, +33251446197, celine.cozic@chd-vendee.fr
- Recruiting
CH du Mans
Le Mans, 72037
Guillaume Direz, PH, +33244710730, gdirez@ch-lemans.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Christelle Darrieurtort, PH, 02 40 08 48 25, christelle.darrieutort@chu-nantes.fr
- Recruiting
Chotard Emilie
Rennes, 35203
Emilie CHotard, PH, +33299267140, emilie.chotard@chu-rennes.fr
About this study
Official title: 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).
Read the 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
- Being tested
- tight control management, standard follow-up
- Keywords
- Rotator cuff tendinopathy, tight control, injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tight control managementOther
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.
standard follow-upOther
Patients are monitored according to standard practice
| Study group | Role | What they receive |
|---|---|---|
| Tight control group | Experimental | 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. Receives: Other: tight control management |
| Control group | Active comparator | 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. Receives: Other: standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Measured: 6 months
Secondary outcomes (6)
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Measured: 3 months and 12 months
pain at motion
Visual Analogic Scale / 100 mm
Measured: 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.
Measured: 3 Months, 6 months, 12 months
Insomnia Severity Index
7 item auto-questionnaire
Measured: 3 Months, 6 months, 12 months
number of shoulder surgeries
patients requiring shoulder surgery to manage their shoulder pain and/or disability
Measured: 12 months
medico-economic study
Incremental cost-utility ratio (cost per QALY, Quality- Adjusted Life-Years)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start25 Nov 2024
- Primary completion25 Nov 2027 (estimated)
- Study completion25 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517680
- Sponsor's protocol ID
- RC23_0421
- Acronym
- GREAT
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tight Treatment in Rotator Cuff Tendinopathy Rotator Cuff Tendinopathy: a Randomized Controlled Trial Versus Standard Standard Management
- ClinicalTrials.gov ID
- NCT06517680
- Acronym / sponsor ID
- GREAT / RC23_0421
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Rotator cuff tendinopathy, tight control, injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Nov 2027 (estimated)
- Study completion
- 25 Nov 2027 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight control group | Experimental | Other: tight control managementPatients 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 | Active comparator | Other: standard follow-upPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tight control managementPatients 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 group |
| standard follow-upPatients are monitored according to standard practice | Other | Control group |
Primary outcome
Oxford Shoulder Score
Time frame: 6 months
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
6 secondary outcomes
Oxford Shoulder Score
Time frame: 3 months and 12 months
pain at motion
Time frame: 3 Months, 6 months, 12 months
Pain Self-Efficacy Questionnaire
Time frame: 3 Months, 6 months, 12 months
Insomnia Severity Index
Time frame: 3 Months, 6 months, 12 months
number of shoulder surgeries
Time frame: 12 months
medico-economic study
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Tendinopathy
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Recruiting
Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
Rotator Cuff Related Shoulder Pain, Rotator Cuff Tendinopathy
Active, not recruiting
Subacromial Corticosteroid Injection Combined With Exercise in Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Effects of Rotator Cuff Drills Versus Progressive Resistance Exercises on Chronic Rotator Cuff Tendinopathy
Rotator Cuff Tendinosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard follow-up in people with Rotator Cuff Tendinopathy, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle Darrieutort, PH (02 40 08 48 25, christelle.darrieutort@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.