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RecruitingNCT06517680GREATUpdated Jan 15, 2026

Tight Control for Rotator Cuff Tendinopathy

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

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

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.
02

Conditions studied

  • Rotator Cuff Tendinopathy

Keywords

  • Rotator cuff tendinopathy, tight control, injection
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Othertight 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.

  • Otherstandard follow-up

    Patients are monitored according to standard practice

06

What researchers measure

Primary outcomes

  1. Oxford Shoulder Score

    Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. pain at motion

    Visual Analogic Scale / 100 mm

    Time frame: 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.

    Time frame: 3 Months, 6 months, 12 months

  4. Insomnia Severity Index

    7 item auto-questionnaire

    Time frame: 3 Months, 6 months, 12 months

  5. number of shoulder surgeries

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

    Time frame: 12 months

  6. medico-economic study

    Incremental cost-utility ratio (cost per QALY, Quality- Adjusted Life-Years)

    Time frame: 12 months

07

Study locations

8 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06517680
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jul 24, 2024
Start date
Nov 25, 2024
Primary completion
Nov 25, 2027 (estimated)
Completion
Nov 25, 2027 (estimated)
Last update
Jan 15, 2026

Study contacts

Christelle Darrieutort, PH
Contact
christelle.darrieutort@chu-nantes.fr
02 40 08 48 25

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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