NCT06517680

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Nov 2027

First Submitted

Initial submission to the registry

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

July 18, 2024

Last Update Submit

January 13, 2026

Conditions

Rotator Cuff Tendinopathy

Keywords

Rotator cuff tendinopathy, tight control, injection

Outcome Measures

Primary Outcomes (1)

  • Oxford Shoulder Score

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

    6 months

Secondary Outcomes (6)

  • Oxford Shoulder Score

    3 months and 12 months

  • pain at motion

    3 Months, 6 months, 12 months

  • Pain Self-Efficacy Questionnaire

    3 Months, 6 months, 12 months

  • Insomnia Severity Index

    3 Months, 6 months, 12 months

  • number of shoulder surgeries

    12 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: standard follow-up

Interventions

standard follow-upOTHER

Patients are monitored according to standard practice

Control group
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.

Tight control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU Angers

Angers, 49033, France

RECRUITING

CHU de Brest

Brest, 29200, France

RECRUITING

CHRU de Tours

Chambray-lès-Tours, 37170, France

RECRUITING

CH Cholet

Cholet, 49325, France

RECRUITING

CH Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

CH du Mans

Le Mans, 72037, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Chotard Emilie

Rennes, 35203, France

RECRUITING

Central Study Contacts

Christelle Darrieutort, PH

CONTACT

02 40 08 48 25christelle.darrieutort@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

November 25, 2024

Primary Completion (Estimated)

November 25, 2027

Study Completion (Estimated)

November 25, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(8)