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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Christelle Darrieutort, PH contact

02 40 08 48 25

christelle.darrieutort@chu-nantes.fr

8 sites in 1 country

France8 sites, 8 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

    Recruiting

Other trials in France

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.
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 groups in NCT06517680
Study groupRoleWhat they receive
Tight control groupExperimentalPatients 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 groupActive comparatorPatients 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.

  1. 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)
  1. 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

  2. pain at motion

    Visual Analogic Scale / 100 mm

    Measured: 3 Months, 6 months, 12 months

  3. 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

  4. Insomnia Severity Index

    7 item auto-questionnaire

    Measured: 3 Months, 6 months, 12 months

  5. number of shoulder surgeries

    patients requiring shoulder surgery to manage their shoulder pain and/or disability

    Measured: 12 months

  6. 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.

  1. First posted24 Jul 2024
  2. Study start25 Nov 2024
  3. Primary completion25 Nov 2027 (estimated)
  4. Study completion25 Nov 2027 (estimated)

Resources

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)
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

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.

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